Treatment methods using handheld devices for disorders

ABSTRACT

A method to treat a dry eye condition of an individual, includes: receiving a switch signal generated based on a manipulation of a control switch at a handheld device; and activating a motor in response to the switch signal to oscillate a member at an oscillation frequency, the member having an elongated configuration, and having a portion for placement outside the individual; wherein the oscillation frequency is sufficient to induce tear production when the portion of the member is applied towards a surface of a body portion of the individual.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.17/450,493 filed on Oct. 11, 2021, pending, which is a continuation ofU.S. Pat. Application No. 16/057,787 filed on Aug. 7, 2018, now U.S.Pat. No. 11,141,348, which claims priority to, and the benefit of, U.S.Provisional Pat. Application No. 62/635,471 filed Feb. 26, 2018, lapsed,U.S. Provisional Pat. Application No. 62/656,177 filed Apr. 11, 2018,lapsed, and U.S. Provisional Pat. Application No. 62/659,582 filed Apr.20, 2018, lapsed. The entire disclosures of the above applications areexpressly incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to medical devices and methods.More particularly, the present disclosure relates to devices and methodsfor stimulating or inhibiting nerves and/or treating conditions, such ascongestion, keratoconjunctivitis sicca, sinusitis, carpal tunnelsyndrome, eye conditions, a skin condition, acne, cysts, or any othercondition.

BACKGROUND

New methods and devices for treating different medical conditions aredescribed herein. One or more embodiments described herein utilizemechanical vibration (such as therapeutic sound, ultrasound, mechanicalperturbation, etc.) in the treatment of one or more conditions, such ascongestion, sinusitis, and/or dry eye.

SUMMARY

In an exemplary first aspect, the present disclosure provides a methodfor stimulating tear production in a patient. The method comprisespositioning a vibratory surface at a bony region on the patient’s facecommunicating with a parasympathetic nerve which innervates the lacrimalgland. The vibratory surface is vibrated at a frequency and adisplacement selected to stimulate the lacrimal nerve to produce tears.Typically, the vibratory surface will stimulate an afferent nerve whichcommunicates with a parasympathetic nerve which stimulates glandsrelated to the tear film.

The vibratory surface may be vibrated at any frequency effective tostimulate the target nerves, typically being in a range from 10 Hz to1000 Hz, 10 Hz to 500 Hz, 10 Hz to 400 Hz, 10 Hz to 300 Hz, 10 Hz to 200Hz, 10 Hz to 100 Hz, 10 Hz to 50 Hz, 50 Hz to 1000 Hz, 50 Hz to 500 Hz,50 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hz to 200 Hz, 50 Hz to 100 Hz, 200Hz to 1000 Hz, 200 Hz to 500 Hz, 200 Hz to 400 Hz, 200 Hz to 300 Hz, 300Hz to 1000 Hz, 300 Hz to 500 Hz, 300 Hz to 400 Hz, or 400 Hz to 1000.Similarly, the vibratory surface may be vibrated at any displacementeffective to stimulate the target nerves, typically being in a rangefrom 0.1 mm to 5 mm, 0.25 mm to 5 mm, 0.5 mm to 5 mm, 1 mm to 5 mm, 0.1mm to 3 mm, 0.25 mm to 3 mm, 0.5 mm to 3 mm, 1 mm to 3 mm, 0.1 mm to 5mm, 0.25 mm to 2 mm, 0.5 mm to 2 mm, 1 mm to 2 mm, or 2 mm to 3 mm.

The vibratory surface typically has a skin contact area in a range from0.5 mm² to 20 mm², 0.5 mm² to 10 mm², 0.5 mm² to 5 mm², 0.5 mm² to 2mm², 0.5 mm² to 1.5 mm², 0.5 mm² to 1 mm², 1 mm² to 20 mm², 1 mm² to 10mm², 1 mm² to 5 mm², 1 mm² to 2 mm², 1 mm² to 1.5 mm², 1.5 mm² to 20mm², .5 mm² to 10 mm², 1.5 mm² to 5 mm², 1.5 mm² to 2 mm², 2 mm² to 20mm², 2 mm² to 10 mm², 2 mm² to 5 mm², 2.5 mm² to 20 mm², 2.5 mm² to 10mm², 2.5 mm² to 5 mm², 5 mm² to 20 mm², or 5 mm² to 10 mm².

The vibratory surface typically has a hardness in a range from Shore A40to Shore A80, Shore A50 to Shore A80, Shore A60 to Shore A80, Shore A70to Shore A80, Shore A40 to Shore A70, Shore A50 to Shore A70, Shore A60to Shore A70, Shore A40 to Shore A60, Shore A50 to Shore A60, or ShoreA40 to Shore A50.

The vibratory surface is usually formed on a polymeric interface bodyand may have a thickness in a range from 1 mm to 10 mm, 2 mm to 10 mm, 3mm to 10 mm, 4 mm to 01 mm, 5 mm to 10 mm, 6 mm to 10 mm, 7 mm to 10 mm,8 mm to 10 mm, 9 mm to 10 mm, 1 mm to 5 mm, 2 mm to 5 mm, 3 mm to 5 mm,4 mm to 5 mm, 1 mm to 4 mm, 2 mm to 4 mm, 3 mm to 4 mm, 1 mm to 3 mm, 2mm to 3 mm, or 1 mm to 2 mm.

In some embodiments, the vibratory surface may be positioned on thepatient’s face at a location where the patient’s upper lateral nasalcartilage meets the patient’s nasal bone. In such cases, the vibratorysurface may be engaged against the patient’s face with an upwarddirectionality.

In some embodiments, the vibratory surface may be positioned at alocation from 6.5 mm to 8.5 mm lateral to the patient’s nasal midline atthe region.

In some embodiments, the vibratory surface may be positioned proximateor over the parasympathetic nerve which innervates the lacrimal glandand travels through the sphenopalatine ganglia located close to themaxillary bone in the sphenopalatine fossa.

In some embodiments, the vibratory surface may be positioned by engagingthe vibratory surface on a handheld device against the bony region.Usually, a patient engages the vibratory surface of the handheld deviceagainst the bony region.

In some embodiments, the vibratory surface moves in a substantiallylinear direction in one dimension. For example, the vibratory surfacemay be driven in a substantially linear direction with an excursion of0.5 to 2 mm.

In some embodiments, the vibratory surface may be placed in a positionto stimulate the external nasal nerve.

In an exemplary second aspect, the present disclosure provides ahandheld device for stimulating tear production in a patient. The devicecomprises a housing having a vibratory surface configured to engage abony region on the patient’s face over an afferent nerve whichcommunicates with a parasympathetic nerve which innervates glandsrelated to the tear film. Circuitry within the housing is configured tovibrate the vibratory surface at a frequency and a displacement selectedto stimulate the afferent nerve, the lacrimal nerve to produce tears,goblet cells to secrete mucin, and the Meibomian glands to produce oilsto maintain the tear film.

Exemplary frequencies, displacements, skin contact areas for thevibratory surfaces, and other design features of the vibratory surfacesand devices have been set forth above with respect to the firstexemplary aspects of the present disclosure.

In other aspects of the methods and handheld device of the presentdisclosure, the device circuitry may be configured to vibrate vibratorysurface with a pulsed duty cycle of 90%, 75%, 50%, 25%, or 10 %. Inspecific embodiments, the circuitry may be configured to increase a peakdisplacement of the vibratory surface when the duty cycle is less than100%.

The handheld device may be configured to be positioned by the patient sothat the vibratory surface engages the vibratory surface against thebony region.

The circuitry may be configured to allow adjustment of the vibrationalfrequency. For example, the handheld device may include a manualfrequency adjustment interface.

The vibrational transducer of the handheld device is typically at leastone ultrasonic vibrational transducer, usually operating at a frequencyin a range from 20 kHz to 30 MHz or from 3 MHz and 10 MHz. The hand helddevice may further comprise at least one non-ultrasonic vibrationaltransducer, typically operating at a frequency in a range from 10 Hz to1000 Hz, 10 Hz to 500 Hz, 10 Hz to 400 Hz, 10 Hz to 300 Hz, 10 Hz to 200Hz, 10 Hz to 100 Hz, 10 Hz to 50 Hz, 50 Hz to 1000 Hz, 50 Hz to 500 Hz,50 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hz to 200 Hz, 50 Hz to 100 Hz, 200Hz to 1000 Hz, 200 Hz to 500 Hz, 200 Hz to 400 Hz, 200 Hz to 300 Hz, 300Hz to 1000 Hz, 300 Hz to 500 Hz, 300 Hz to 400 Hz, or 400 Hz to 1000 Hz.

In some embodiments, therapeutic sound or ultrasound or mechanicalvibrations is utilized to treat dry eye by stimulating the lacrimalglands or the nasolacrimal duct.

In some embodiments, therapeutic ultrasound is utilized to stimulatenerves which travel to the lacrimal gland in the eye.

In some embodiments, therapeutic ultrasound is utilized to open upMeibomian glands inside an eyelid.

In some embodiments, therapeutic ultrasound or sound is utilized tostimulate a lacrimal duct via the nose in a patient.

In some embodiments, therapeutic sound or ultrasound is utilized tostimulate secretion of tears.

In some embodiments, therapeutic sound, ultrasound, or mechanicalvibration is utilized to stimulate the external branch of the anteriorethmoidal nerve (external nasal nerve) to create tears or decongest thesinus or nasal cavities.

In some embodiments, therapeutic sound is coupled to skin covering bonystructures and a frequency of sound is applied to the skin such that thebone underneath resonates in response to the sound and the resonationthrough the bone activates nerves in close proximity to the bone.

In some embodiments, therapeutic sound is delivered through endeffectors which propagate the sound and transduce it to the bonystructures of the head and neck with optimal safety and effectiveness.

In some embodiments, therapeutic sound is used to stimulate thesphenopalatine ganglia and associated nerves in the pterygopalatinefossa by transducing sound through the skin overlying the maxillarybone.

In some embodiments, therapeutic sound, vibration, or ultrasound isutilized to stimulate the external branch of the anterior ethmoidalnerve (external nasal nerve) at the region of the nose where the nasalbone meets the lateral process of the septal nasal cartilage.

In some embodiments, therapeutic sound or ultrasound is utilized tostimulate the sphenopalatine ganglia to treat cold symptoms such asstuffed or congested nasal passageways.

In some embodiments, therapeutic sound, vibration, or ultrasound isutilized to inhibit the sphenopalatine ganglia.

In some embodiments, external ultrasound and/or mechanical vibration areapplied to the region where the nasal bone meets the nasal cartilage tostimulate the nerves related to the sphenopalatine ganglia or theethmoidal nerves to increase tears and treat dry eye.

In some embodiments, external ultrasound and/or mechanical vibration areapplied to the region where the nasal bone meets the nasal cartilage tostimulate the external nasal nerve to treat congestion, sinusitis, or acombination thereof.

In some embodiments, external ultrasound and/or mechanical vibration areapplied to a region adjacent to or on top of the median nerve, forexample on a ventral side of a wrist of an individual, to treat carpaltunnel syndrome.

In some embodiments, external ultrasound and/or mechanical vibration areapplied to a skin surface to treat any skin condition, for examplepsoriasis, acne, aging, cysts (e.g., sebaceous cysts), eczema, rosacea,seborrheic dermatitis, hemangiomas, cold sores, warts, cutaneousCandidiasis, carbuncles, cellulitis, hypohidrosis, impetigo, cankersores, Herpes infections, seborrheic keratosis, actinic keratosis (i.e.,age spots), corns, calluses, mouth ulcers, or any other skin conditionknown in the art.

For example, external ultrasound and/or mechanical vibration are appliedto a skin surface to unplug follicles, for example plugged withaccumulations of dead skin from the lining of the pore, to treat and/orprevent acne. Additionally or alternatively, external ultrasound and/ormechanical vibration are applied to disrupt acne forming bacteria, forexample Propionibacterium acnes, in pores. Such bacteria accumulate inpores plugged or clogged with dead skin cells and/or accumulated sebum.

For example, external ultrasound and/or mechanical vibration are appliedto a skin surface to unplug or inhibit sebaceous glands, for examplethat become plugged at the base of pores or that over-produce sebum, totreat and/or prevent acne.

For example, external ultrasound and/or mechanical vibration are appliedto a skin surface to inhibit inflammation generated by the immune systemwhich can cause redness, irritation, and swelling.

For example, external ultrasound and/or mechanical vibration are appliedto a skin surface to induce firmness, collagen formation, and/orfibroblastic activity to increase skin youthfulness and reduce aging andwrinkles.

For example, external ultrasound and/or mechanical vibration are appliedto a skin region adjacent to or on top of a cyst to disrupt the cyst andinduce healing.

One aspect of the present disclosure relates to a method to treat anerve of the facial region. In some embodiments, the method includes:applying a handheld device with an applicator tip to the skin of a faceof a patient, the skin covering a facial bony region immediatelythereunder; depressing the applicatory tip on the skin toward the boneof the face of the patient such that further depression is prevented;and delivering vibratory energy from the handheld device, through theapplicator tip of the device, through the skin of the patient andthrough the bone of the patient to stimulate or inhibit a nerve of thehead and neck region of the patient.

In some embodiments, the vibratory energy has a frequency from about 50Hz to about 1 KHz. In some embodiments, the vibratory energy has afrequency from about 100 Hz to about 500 Hz.

In some embodiments, the handheld device is applied to the side of anose of patient and depressed against the nasal bone along the side ofthe nose at the region where the cartilage meets the bone to stimulatetears in the patient. In some embodiments, the handheld device isapplied to the side of a nose of the patient at the location where thenasal cartilage and the nasal bone meet. In some embodiments, thehandheld device is depressed along the side of the nose at the locationwhere the nasal cartilage and the nasal bone meet; and, applying afinger to the contralateral side of the nose concomitantly. In someembodiments, the handheld device is applied to both sides of the nose ofthe patient either simultaneously or sequentially during therapy.

In some embodiments, the handheld device delivers vibratory energy at adecibel (db) level less than about 20 db. In some embodiments, thehandheld device delivers the vibratory energy at a decibel level lessthan about 10 db.

In some embodiments, the method includes stimulating a nerve of the headand neck region to create tearing from the eye. In some embodiments, themethod includes stimulating a sphenopalatine ganglia of the patient togenerate tears from the lacrimal gland of the patient. In someembodiments, the method includes stimulating the nasolacrimal duct togenerate tears in the eye of the patient.

In some embodiments, the vibratory frequency is adjusted to optimize thestimulation or inhibition of the nerve. In some embodiments, thevibratory amplitude is adjusted to optimize the stimulation orinhibition of the nerve.

In some embodiments, the method includes attaching the applicator tip toa finger tip and pressing the fingertip to the skin of the nose in theregion where the nasal bone meets the nasal cartilage. In someembodiments, the method includes attaching the applicator tip to twofingers; and, applying the vibratory energy to the bone by pinching theregion of the nose with the two fingers.

In some embodiments, the method includes holding the applicator to oneside of the nose with a first hand while adjusting its pressure on theskin by pressing against the other side of the nose with a differentfinger of the same hand. In some embodiments, the method includes oneof: adjusting the angle of application, the pressure against the skin,and the type of applicator tip based on feedback from the patient of asensation of tearing.

In some embodiments, the method includes touching the applicator tip toa region of the face to affect a change in a congestion condition suchas one of: sinusitis, nasal congestion, and rhinitis.

Another aspect of the present disclosure is directed to a device tostimulate a nerve in the head and neck region of a patient. In someembodiments, the device includes: an applicator with a connectedapplicator handle, an actuator coupled to the handheld applicator, and abody surface interface mechanically coupled to the actuator, such thatthe actuator moves mechanically at a frequency driven by an electriccurrent and voltage to generate vibrational energy, and the body surfaceinterface is adapted to couple to a skin interface of the head and neckregion of the patient to transmit vibrational energy to a bone throughthe skin, and to stimulate a nerve acoustically coupled to the bonethrough the skin.

In some embodiments, the actuator vibrates at a frequency of between 100and 300 Hz. In some embodiments, the actuator is coupled to a materialsuch that the material moves with a planar excursion of about 500microns and not more than about 1500 microns.

In some embodiments, the body surface interface is adapted to couple toa nasal bridge. In some embodiments, the body surface interface isadapted to simultaneously couple to both sides of a nose. In someembodiments, the body surface interface has the compliance of a pencileraser.

In some embodiments, the handheld applicator is adapted to be worn on awrist and the actuator is separated from the handheld actuator by aflexible wire. In some embodiments, the handheld applicator furtherincludes a portable battery.

In some embodiments, the nerve is part of, or communicates with, asphenopalatine ganglia. In some embodiments, the vibrational energy isconfigured to resonate with the bone overlying the nerve to stimulatethe nerve. In some embodiments, the skin surface interface is adapted tobe grasped between the fingers of the patient. In some embodiments, theskin surface interface is connected to a pair of spectacles. In someembodiments, the skin surface interface further includes a combinationof a rigid material and a malleable material. In some embodiments, theskin surface interface further is adapted to direct the vibrationalenergy preferentially in one direction to couple the vibrational energyto the bone underlying the skin and the handheld applicator is isolatedfrom the movement and vibration.

In some embodiments, the nerve is a branch of facial nerve. In someembodiments, the nerve is a lacrimal nerve.

In some embodiments, the device includes an adjustment control to varythe vibration frequency and/or the amplitude of the actuator. In someembodiments, the applicator is handheld. In some embodiments, theapplicator is configured to be attached to a finger. In someembodiments, the applicator is configured to be attached to two fingerssuch that the bridge of the nose can be pinched with two actuators totransmit vibration to the nerve of the head or neck regionsimultaneously. In some embodiments, the applicator is configured to beattached to the wrist of the patient. In some embodiments, theapplicator is configured to be attached to a pair of spectacles. In someembodiments, the applicator is configured to be applied to an eyelidappliance.

In some embodiments, the body surface interface is adapted to couplevibrations from the actuator to the bone underneath the skin. In someembodiments, the body surface interface comprises a semi-rigid material.In some embodiments, the body surface interface is adapted to couple tothe finger of a user and wherein the body surface interface furtherincludes a second interface which couples to a second finger of a user.In some embodiments, the body surface interface includes or is formed ofa shape memory material to facilitate form fitting to the tissue of theouter region of a nose of a user.

In some embodiments, the device includes a controller which enablesmodulation of the amplitude of the vibration of the body surfaceinterface.

In some embodiments, the vibrational energy is adapted to activate apressure sensitive nerve. In some embodiments, the actuator impartsmotion to the body surface interface in which the motion is linear andis adapted to apply to the skin surface so that the motion isapproximately perpendicular to the skin surface. In some embodiments,the actuator imparts motion to the body surface interface in which themotion is linear and is adapted to apply to the skin surface so that themotion is perpendicular to the skin surface and can be adjusted so thatthe motion is applicable at an angle to the skin surface. In someembodiments, the actuator imparts motion to the body surface interfacein which the motion is linear and is adapted to apply to the skinsurface while vibrations to the hand of the user are minimized. In someembodiments, the actuator is electrically connected to a controller inwhich the controller imparts an adjustable frequency control. In someembodiments, the actuator is electrically connected to a controller inwhich the controller imparts an adjustable amplitude control. In someembodiments, the actuator is a solenoid with an electromagnet to impartlinear direction to the body surface interface. In some embodiments, theactuator is a speaker or a voice activated coil. In some embodiments,the actuator has a linear actuator component such that vibrations areisolated from the user of the device.

In some embodiments, the body surface interface is rigid with an edge ofapproximately 1-2 mm width and configured to fit in the ridge at thejunction of the nasal bone and nasal cartilage. In some embodiments, thebody surface interface further includes an edge adapted to at leastpartially retract an eyelid.

In some embodiments, the actuator is connected to cam, and the camdrives a piston to create a linear motion.

In some embodiments, the cam is attached to a rod which connects to aposition offset from the central axis of the motor so as to create alinear motion of the piston, the excursion of which is proportional tothe offset from the central axis. In some embodiments, the offsetresults in a 1 mm excursion of the piston. In some embodiments, theoffset results in a 2 mm excursion of the piston. In some embodiments,the offset results in a 0.5 mm excursion of the piston.

In some embodiments, the device includes an electronic control circuit,such that the electronic control circuit outputs a programmable voltagewhich determines the revolutions per minute of the motor and thereforethe excursion frequency of the piston. In some embodiments, the linearmotion applicator is adapted to apply a force of about 1N to 5N to aregion of the face overlying a nerve to activate the nerve with periodicapplication of this force through the skin to reach the nerve underlyingthe skin to create a clinical effect in a patient.

In some embodiments, the method includes: placing the handheld device onthe region along the skin along the side of the nose where the nasalbone and the nasal cartilage meet; firmly pressing into this region;and, applying vibratory energy from the handheld device with a frequencyof about 100-300 Hz and an excursion of the device tip of about 0.5 mmto about 1.5 mm.

In some embodiments, the method includes targeting the anteriorethmoidal nerve.

In some embodiments, the method includes: setting the handheld device togenerate ultrasound pressure waves with frequency of about 500 kHz toabout 5 MHz.

In some embodiments, the method includes activating the anteriorethmoidal nerve.

In some embodiments, the method includes applying pressure to thehandheld device along the skin of the patient so that the patient feelsa sneezing or tearing sensation. In some embodiments, the methodincludes applying a range of frequencies of pressure waves to determinethe optimal frequency and degree of pressure to achieve the effect ofsneezing or tear production.

In some embodiments, a sphenopalatine ganglia is activated by applyingthe handheld device to the external nasal nerve.

Another aspect of the present disclosure is directed to a method totreat a nerve of the facial region. In some embodiments, the methodincludes: applying a handheld device with an applicator tip to the skinof a face of a patient, the skin covering a bony region of the face;depressing the applicator tip on the skin toward the bone of the face ofthe patient; and delivering vibratory energy from the handheld device,through the applicator tip of the device, through the skin of thepatient and through the bone of the patient to create a biologic effectin a mucosal region underlying the bone.

In some embodiments, the method includes: delivering the vibratoryenergy via applicator tip with a frequency of approximately 100-300 Hzand an excursion of 0.5 m to 2.0 mm. In some embodiments, the methodincludes: delivering vibratory energy via applicator tip with afrequency of approximately 300 Hz to 50 kHz. In some embodiments, themethod includes: delivering vibratory energy via applicator tip with afrequency of approximately 50 kHz to 10 MHz.

Another aspect of the present disclosure is directed to a method totreat a nerve of the facial region. In some embodiments, the methodincludes: applying a handheld device with an applicator tip to the skinof a face of a patient, the skin covering a bony region of the face, thebony region coupled to an autonomic nerve; depressing the applicationtip on the skin toward the bone of the face of the patient; anddelivering vibratory energy from the handheld device, through theapplicator tip of the device, through the skin of the patient andthrough the bone of the patient to create a biologic effect in a mucosalregion underlying the bone.

In some embodiments, the mucosal region is a sinus cavity or a nasalpassage.

In some embodiments, the vibratory energy has a frequency of between 50Hz and 5 MHz.

In some embodiments, the method includes: cycling the vibratory powerwith a duty cycle, a peak power, and/or an average power.

In some embodiments, the method includes performing a surgical procedureprior to, during or after delivery of the vibrational energy. In someembodiments, the method includes locating a sinus or a region ofcongestion using an acoustic impulse. In some embodiments, the methodincludes: simultaneously utilizing multiple vibratory frequencies.

In some embodiments, the method includes: applying one vibratory energywith a frequency between 50 and 300 Hz and a second vibratory energy ofbetween about 1 MHz and 30 MHz.

In some embodiments, the method includes: mapping the nerve anatomy ofthe nasal region prior to applying the vibratory energy.

In some embodiments, the method includes: activating the activator tipto deliver vibratory energy with a frequency between 1 MHz and 10 MHz.In some embodiments, the method includes: activating the activator tipto deliver vibratory energy with a frequency between 0.5 MHz and 5 MHz.In some embodiments, the method includes: activating the activator tipto deliver a vibratory energy with a frequency between 50 Hz and 500 Hz.

In some embodiments, the method includes: stimulating a parasympatheticnerve to create a tearing response.

Another aspect of the present disclosure is directed to a method totreat patient with dry eye. In some embodiments, the method includes:applying a handheld device with an applicator tip to the skin of a faceof a patient, the skin covering a bony region of the face; depressingthe applicator tip on the skin toward the bone of the face of thepatient in the region where the nasal cartilage meets the nasal bone;and delivering vibratory energy from the handheld device with afrequency between 100 Hz and 400 Hz and an amplitude of the applicatortip greater than 500 microns to the region where the nasal cartilagemeets the nasal bone to stimulate tears in the eyes of the patient.

In some embodiments, the method includes: setting the frequency to afrequency between 150 and 200 Hz.

Another aspect of the present disclosure is directed to a method totreat a patient with nasal or sinus disease. In some embodiments, themethod includes: applying a sound or ultrasound applicator to the skinsurrounding the nasal sinuses; setting an amplitude and a frequency ofthe applicator applied to the skin; and delivering sound or ultrasoundenergy from the applicator to the skin of the patient and through theskin of the patient to the nasal or sinus mucosa of the patient.

In some embodiments, the disease is an allergic disease and the sound orultrasound overstimulates the nerves to inhibit their function in theallergic disease.

In some embodiments, the method includes delivering the sound orultrasound prior to, during, or after balloon sinuplasty. In someembodiments, the sound or ultrasound comprises frequency between 50 Hzand 300 Hz. In some embodiments, the method includes delivering sound orultrasound just prior to, during, or after a functional endoscopic sinussurgery procedure (FESS). In some embodiments, the sound and ultrasoundare delivered to the region of the external nasal nerve at the junctionof the nasal cartilage and nasal bone.

Another aspect of the present disclosure is directed to a method ofcreating tears in a patient. In some embodiments, the method includes:gripping a device with one hand and applying it to provide for vibrationat 100 to 300 Hz with an approximately linear excursion of the tip ofthe device of about 500 to 1500 microns; applying the device to theregion of the external part of the nose where the nasal cartilage meetsthe nasal bone; and activating the external nasal nerve.

In some embodiments, the method includes applying a force of about 0.5 Nto about 3.0 N to the external nasal nerve. In some embodiments, themethod includes applying a force of about 0.5 N to about 5.0 N.

Another aspect of the present disclosure is directed to a method totreat dry eye. In some embodiments, the method includes: applying avibrating implement to a region proximate an eyelid or nose of apatient; determining a set of test vibration parameters of theimplement; determining a location and optimal range of vibrationfrequency and amplitude of the implement based on patient and operatorfeedback; and setting the vibration frequency and amplitude of theimplement based on the patient and/or operator feedback.

In some embodiments, the implement further comprises ultrasound withfrequency between 1 MHz and 30 MHz and the optimal frequency isdetermined by the patient/user.

In some embodiments, the location is set to the region where the nasalbone meets the nasal cartilage.

In some embodiments, the user further depresses the skin on the side ofthe face opposite the side where the implement is being applied.

In some embodiments, the user depresses the skin on the nose on the sideopposite the placement of the implement and depresses the implementsimultaneously to transmit vibrations and activate nerves on both sidesof the face.

In some embodiments, the location is proximate an infra-orbital nerve.In some embodiments, the location is proximate to a sphenopalatineganglia. In some embodiments, the location is proximate an ethmoidalnerve. In some embodiments, the location is a lacrimal gland. In someembodiments, the location is an accessory lacrimal gland. In someembodiments, the location is the skin of the eyelid and the amplitudeand frequency are chosen to eliminate wrinkles in the eyelid.

In some embodiments, the vibration frequency is chosen from a frequencybetween 50 Hz and 300 Hz; and the amplitude is chosen from about 0.1 mmto about 1.5 mm; and wherein the amplitude is sinusoidal; and whereinthe implement moves with a substantially linear motion.

Another aspect of the present disclosure is directed to a method togenerate tears in a human subject. In some embodiments, the methodincludes: applying an applicator to an external region of a nose of asubject, the region located where the external branch of the anteriorethmoidal nerve exits to the skin alongside the nose; and activating theapplicator to generate mechanical vibration at a frequency of between100 and 300 Hz, the vibration generating a force on the skin andunderlying nerve sufficient to activate the nerve.

In some embodiments, the method includes: actively mapping nerves in theskin distributions on the face of a subject to determine the optimumlocation for stimulation of the exterior anterior ethmoidal nerve. Insome embodiments, the active mapping includes stimulating the nerves inthe skin distributions on the face of the subject with a range offrequencies of between 50 Hz and 300 Hz, a range of amplitudes between0.5 mm and 3.0 mm and a range of forces between 0.5 N and 3 N. In someembodiments, the active mapping further includes monitoring the effectof the stimulation of the nerves.

In some embodiments, the active mapping includes monitoring one of:tearing, sneezing, blood flow, nasal mucosa fullness, and itching.

In some embodiments, the method includes determining one of: optimumfrequency, position, force, amplitude, duration, power, and duty cycle.In some embodiments, the method includes: positioning the applicatorspecifically along the mapped regions.

Another aspect of the present disclosure is directed to a method togenerate tears in a human subject. In some embodiments, the methodincludes: applying an applicator to an external region of a nose of asubject, the region located where the external branch of the anteriorethmoidal nerve exits to the skin alongside the nose; activating theapplicator to generate mechanical vibration at a frequency of between 50Hz and 300 Hz; and applying a force over an area of about 1 mm² to about5 mm² on the skin and underlying nerve of approximately 0.5 N to about 2N to activate the nerve.

Another aspect of the present disclosure is directed to deviceconfigured to activate tears in a human patient. In some embodiments,the device includes: an end effector configured to interface with theexternal skin over the region of the nose where the external nasal nerveexits the nasal bone; a main body configured to be handheld; and anactuation mechanism coupled to the end effector and configured toproduce mechanical vibration of the end effector.

In some embodiments, the end effector is configured to apply 0.5 N to3.0 N force over an area of about 1 mm² to about 5 mm². In someembodiments, the end effector includes an edge radius of curvature of0.5 mm to 2.0 mm. In some embodiments, the end effector includes a notchto fit in the region of the interface of the nasal cartilage and nasalbone. In some embodiments, the end effector further includes or isformed of a biocompatible material with a durometer between 20A and 60A.In some embodiments, the end effector is actuated to move a distance ofbetween 5 mm and 30 mm. In some embodiments, the end effector isactuated to move a distance of between 5 mm and 30 mm while maintainingrelatively constant force of between 0.5 N and 3.0 N.

In some embodiments, the actuator includes a linear resonance actuator.In some embodiments, the actuator includes an eccentrically weightedmotor. In some embodiments, the actuator includes a voice coil. In someembodiments, the actuator comprises an electromagnet. In someembodiments, the actuator includes a piezoelectric crystal.

In some embodiments, the actuator is configured to accelerate the endeffector with a linear motion. In some embodiments, the actuator isconfigured to accelerate the end effector in a circular motion. In someembodiments, the actuator is configured to accelerate the end effectorin a sinusoidal pattern. In some embodiments, the actuator is configuredto accelerate the end effector in a programmable pattern. In someembodiments, the actuator is configured to accelerate the end effectorin a pattern which is programmable with a smart phone application.

Another aspect of the present disclosure is directed to a method fortreating rhinitis. In some embodiments, the method includes: deliveringa vibratory stimulus via a probe to treat rhinitis in a patient in needthereof, such that the probe is in contact with one or more tissues ofthe nose of the patient during delivery of the vibratory stimulus.

In some embodiments, the electrical stimulus is delivered in response toone or more symptoms of rhinitis. In some embodiments, the one or moresymptoms of rhinitis include one or more of itching, sneezing,congestion, runny nose, post-nasal drip, mouth breathing, coughing,fatigue, headache, anosmia, phlegm, throat irritation, periorbitalpuffiness, watery eyes, ear pain, and fullness sensation.

In some embodiments, the vibratory stimulus is delivered more than onceper day on a scheduled basis.

In some embodiments, the one or more tissues of the nose is the nasalmucosa. In some embodiments, the one or more tissues of the nose is skinon the outside of the nose. In some embodiments, the one or more nasaltissues is the mucosa adjacent to the nasal septum.

In some embodiments, the vibratory stimulus is a linear motion with anoscillation frequency of about 100 to 300 Hz.

Another aspect of the present disclosure is directed to a method oftreating rhinitis. In some embodiments, the method includes: deliveringa vibratory stimulus to a nasal tissue of a subject to improve rhinitisof the subject, such that the vibratory stimulus is delivered via aprobe comprising a control subsystem to control the vibratory stimulus.

In some embodiments, the vibratory stimulus is delivered in response toone or more symptoms of rhinitis. In some embodiments, the one or moresymptoms of rhinitis comprise one or more of itching, sneezing,congestion, runny nose, post-nasal drip, mouth breathing, coughing,fatigue, headache, anosmia, phlegm, throat irritation, periorbitalpuffiness, watery eyes, ear pain, and fullness sensation.

In some embodiments, the vibratory stimulus is delivered at least oncedaily during a treatment period. In some embodiments, the vibratorystimulus is delivered on a scheduled basis during the treatment period.

Another aspect of the present disclosure is directed to a method fortreating ocular allergy. In some embodiments, the method includes:delivering a vibratory stimulus via probe to treat ocular allergy in apatient in need thereof, wherein the probe is in contact with nasaltissue of the patient during delivery of the vibratory stimulus.

In some embodiments, the vibratory stimulus is delivered in response toone or more symptoms of ocular allergy.

In some embodiments, the one or more symptoms of ocular allergy compriseone or more of swelling, puffiness, itching, tearing, and discharge.

In some embodiments, the nasal tissue is nasal mucosa. In someembodiments, the nasal tissue is the external skin of the nose.

In some embodiments, the vibratory stimulus is a linear motion atapproximately 100 Hz to 300 Hz.

Another aspect of the present disclosure is directed to a method oftreating ocular allergy, including: delivering a vibratory stimulus to anasal tissue of a subject to improve ocular allergy of the subject, suchthat the vibratory stimulus is delivered by a probe of a stimulatorcomprising a control subsystem to control the vibratory stimulus.

In some embodiments, the electrical stimulus is delivered in response toone or more symptoms of ocular allergy. In some embodiments, the one ormore symptoms of ocular allergy comprise one or more of swelling,puffiness, itching, tearing, and discharge.

Another aspect of the present disclosure is directed to a method totreat sinusitis. In some embodiments, the method includes: positioning avibratory surface at a bony region on the patient’s face communicatingwith a parasympathetic nerve; and vibrating the vibratory surface at afrequency and a displacement selected to stimulate the external nasalnerve.

Another aspect of the present disclosure is directed to a method totreat rhinitis. In some embodiments, the method includes: positioning avibratory surface at a bony region on the patient’s face communicatingwith a parasympathetic nerve; and vibrating the vibratory surface at afrequency and a displacement selected to stimulate the external nasalnerve.

Another aspect of the present disclosure is directed to a handhelddevice for applying ultrasound or mechanical vibration to a body portionof an individual to treat a condition of the individual. In someembodiments, the device includes: an effector tip configured tooscillate in substantially one dimension; a motor in contact with theeffector tip, such that the motor induces the substantiallyone-dimensional oscillation of the effector tip; and a power sourceelectrically coupled to the motor. In some embodiments, the effector tipis formed of a material that has a durometer sufficient to inducetherapeutic effects without abrading the body portion of the individual.

In some embodiments, the effector tip is part of a cantilevered beam andthe motor induces reciprocal motion in the cantilevered beam to induceeffector tip oscillation. In some embodiments, the cantilevered beambends when a force is applied to the effector tip, wherein bending thecantilevered beam slows the motor, reduces effector tip oscillation, andunbalances the motor oscillation so that the end effector moves in apreferential direction.

In some embodiments, the device further includes a housing, such thatthe cantilevered beam is coupled to the housing via a coupling element,and a natural frequency of a combination of the cantilevered beam andthe coupling element match an oscillation frequency of the motor. Insome embodiments, the coupling element is a bracket or joint.

In some embodiments, the cantilevered beam includes a characteristicheight dimension, width dimension, and length dimension.

In some embodiments, a frequency of oscillation of the effector tip isdampable when a force of substantially 1 N is applied to the effectortip.

In some embodiments, the device further includes a housing, such thatthe power source and motor are housed in the housing and the effectortip at least partially protrudes from the housing.

In some embodiments, the device further includes a port configured toreceive an adapter therein for charging the power source. In someembodiments, the power source is a rechargeable battery.

In some embodiments, the effector tip oscillates with a substantiallyfixed amplitude in air. In some embodiments, the substantially fixedamplitude is between about 0.25 mm and 1.5 mm.

In some embodiments, the amplitude of oscillation is dampable when aforce of substantially 2 N is applied to the effector tip.

In some embodiments, the durometer is between 40A to 60A.

In some embodiments, the effector tip oscillates with a force of 1 N to3 N.

In some embodiments, a frequency of oscillation of the effector tip is50 Hz to 300 Hz.

In some embodiments, the condition is one or more of: congestion,keratoconjunctivitis sicca, sinusitis, carpal tunnel syndrome, a skincondition, acne, and cysts.

In some embodiments, the device further includes a storage mediumconfigured to store information related to one or more of: a treatmentduration, a treatment start time, a treatment end time, applied forceagainst skin, and a treatment frequency.

In some embodiments, the device further includes a housing and aretractor coupled to the housing, such that the retractor is configuredto retract an eyelid of the individual so that effector tip oscillationis applied to an eye structure. In some embodiments, the eye structureis one or more of: an eyelid, an eyeball, and a structure in or aroundan eye.

In some embodiments, the therapeutic effect is stimulation of a nerve,wherein the nerve is one of: an external nasal nerve, a media nerve, anoptic nerve, a lacrimal nerve, and a parasympathetic nerve.

In some embodiments, the body portion is one of: an eye structure, awrist, a nose region, and a facial region.

In some embodiments, the substantially one-dimensional oscillation ofthe effector tip is perpendicular to the body portion. In someembodiments, a subset of the oscillations of the effector tip isparallel to the body portion. In some embodiments, for every fourperpendicular oscillations there is one parallel oscillation.

Another aspect of the present disclosure is related to an apparatus forquantifying one or more of: a motion, a frequency, and a force of anoscillating device. In some embodiments, the apparatus includes: asensor coupled to one or more members, such that the sensor isconfigured to measure the force exerted by the oscillating device in atleast on direction; a processor electrically coupled to the sensor, suchthat the processor is configured to collect one or more readings fromthe sensor; and a holder configured to position the oscillating devicein contact with the sensor.

In some embodiments, the one or more sensor readings collected by theprocessor are transmitted (e.g., via BlueTooth, RF, NFC, wirelessprotocol, etc.) to an electronic device communicatively coupled to theapparatus.

In some embodiments, the apparatus further includes a frame, such thatthe one or more members are also coupled to the frame and are configuredto suspend the sensor in the frame.

In some embodiments, the one or more readings are collected at greaterthan 200 Hz. In some embodiments, the one or more readings are collectedat 3.95 kHz. In some embodiments, the one or more readings are collectedat greater than 1 kHz.

In some embodiments, the apparatus is configured to estimate a forceoutput of the oscillating device in at least one direction when theoscillating device is preloaded in the one or more members and allowedto reach equilibrium with the one or more members prior to the sensorbeing turned on.

In some embodiments, the apparatus further includes a plate, such thatthe sensor is coupled to the plate which is coupled to the one or moremembers.

In some embodiments, the one or more members are stretchable or elastic.

In some embodiments, the sensor is an accelerometer.

In some embodiments, the oscillating device includes an oscillatingeffector tip, such that the oscillating effector tip is positioned incontact with the sensor.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a dry eye condition of the individual, includes:a housing; a member having a first portion accommodated in the housing,and a second portion that is moveable relative to the housing, whereinthe second portion is for placement outside the individual, and isconfigured to oscillate to apply the mechanical vibration to the bodyportion, the member having an elongated configuration; and a motor inthe housing, the motor configured to oscillate the member at anoscillation frequency sufficient to induce tear production when thesecond portion of the member is applied towards a surface of the bodyportion.

Optionally, the motor is configured to cause the member to undergobending action in a reciprocating manner.

Optionally, the motor is carried by the member.

Optionally, the motor is fixedly attached to the member so that themotor and the member can move together.

Optionally, the member comprises a cantilevered beam having a free end,the second portion being at the free end of the cantilevered beam.

Optionally, the motor is configured to cause the cantilevered beam toundergo bending action in a reciprocating manner.

Optionally, a speed of the motor is variable based on an amount of forceapplied at the second portion of the member.

Optionally, the oscillation frequency of the member is variable based onan amount of force applied at the second portion of the member.

Optionally, the first portion of the member is fixedly coupled to thehousing via a coupling element, and wherein a natural frequency of acombination of the member and the coupling element corresponds with anoscillation frequency of the motor.

Optionally, the coupling element comprises a bracket or joint.

Optionally, an oscillation of the second portion is dampable when aforce of 1 N is applied to the second portion of the member.

Optionally, the handheld device further includes a power sourceaccommodated in the housing.

Optionally, the handheld device further includes a port configured toreceive an adapter for charging the power source.

Optionally, the power source is a rechargeable battery.

Optionally, the second portion of the member is configured to oscillatewith a substantially fixed amplitude in air.

Optionally, the substantially fixed amplitude is anywhere between 0.25mm and 1.5 mm.

Optionally, an oscillation of the second portion is dampable when aforce of 2 N is applied to the second portion of the member.

Optionally, the second portion of the member has a durometer that isanywhere between 40A to 60A.

Optionally, the second portion of the member is configured to oscillatewith a force that is anywhere from 1 N to 3 N.

Optionally, the oscillation frequency of the member is anywhere from 50Hz to 300 Hz.

Optionally, the handheld device further includes a storage mediumconfigured to store information related to a treatment duration, atreatment start time, a treatment end time, an applied force, atreatment frequency, or any combination of the foregoing.

Optionally, the motor is configured to oscillate the member at theoscillation frequency to stimulate a nasal nerve to induce the tearproduction.

Optionally, the body portion comprises a nose region, and the secondportion of the member is configured to apply the mechanical vibration tothe nose region.

Optionally, the body portion comprises a facial region, and the secondportion of the member is configured to apply the mechanical vibration tothe facial region.

Optionally, the second portion of the member is configured for placementover an infraorbital nerve.

Optionally, the second portion of the member is configured for placementover an anterior ethmoidal nerve.

Optionally, the second portion of the member is configured for placementover an external nasal nerve.

Optionally, the second portion of the member is configured for placementover an eyelid or on a sclera of an eye.

Optionally, the second portion of the member is configured for placementalong a sensory portion of an ophthalmic nerve division of a trigeminalnerve.

Optionally, the second portion of the member is configured to apply avibrational force having a first directional component that isperpendicular to a surface of the body portion.

Optionally, the vibrational force has a second directional componentthat is parallel to the surface of the body portion.

Optionally, a first frequency of the first directional component ishigher than a second frequency of the second directional component.

Optionally, the second portion has a curvilinear surface for contactingthe body portion.

Optionally, the second portion has a convex exterior surface.

Optionally, the handheld device further includes a power switch operableby the individual to activate the handheld device.

Optionally, the power switch comprises a button, wherein the handhelddevice is configured to be activated in response to a pressing of thebutton, and is configured to be de-activated when the button isun-pressed.

Optionally, the second portion of the member is outside the housing.

Optionally, the housing comprises an opening, and the second portion ofthe member is configured to oscillate within the opening.

Optionally, the second portion has a thickness measured in a directionthat is parallel to a skin against which the second portion is to beapplied, the thickness being between 0.5 mm and 3 mm.

Optionally, the second portion has a tissue-contacting surface, a sidewall, and a dull corner between the tissue-contacting surface and theside wall.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a dry eye condition of the individual, includes:a housing; a member having a first portion accommodated in the housing,and a second portion that is moveable relative to the housing, whereinthe second portion is for placement outside the individual, and isconfigured to oscillate to apply the mechanical vibration to the bodyportion; and a motor in the housing, the motor configured to cause themember to undergo bending action in a reciprocating manner to oscillatethe second portion of the member at an oscillation frequency sufficientto induce tear production when the second portion of the member isapplied towards a surface of the body portion.

Optionally, the motor is carried by the member.

Optionally, the motor is fixedly attached to the member so that themotor and the member can move together.

Optionally, the member comprises a cantilevered beam having a free end,the second portion being at the free end of the cantilevered beam.

Optionally, a speed of the motor is variable based on an amount of forceapplied at the second portion of the member.

Optionally, the oscillation frequency of the member is variable based onan amount of force applied at the second portion of the member.

Optionally, the first portion of the member is fixedly coupled to thehousing via a coupling element, and wherein a natural frequency of acombination of the member and the coupling element corresponds with anoscillation frequency of the motor.

Optionally, the coupling element comprises a bracket or joint.

Optionally, an oscillation of the second portion is dampable when aforce of 1 N is applied to the second portion of the member.

Optionally, the handheld device further includes a power sourceaccommodated in the housing.

Optionally, the handheld device further includes a port configured toreceive an adapter for charging the power source.

Optionally, the power source is a rechargeable battery.

Optionally, the second portion of the member is configured to oscillatewith a substantially fixed amplitude in air.

Optionally, the substantially fixed amplitude is anywhere between 0.25mm and 1.5 mm.

Optionally, an oscillation of the second portion is dampable when aforce of 2 N is applied to the second portion of the member.

Optionally, the second portion of the member has a durometer that isanywhere between 40A to 60A.

Optionally, the second portion of the member is configured to oscillatewith a force that is anywhere from 1 N to 3 N.

Optionally, the oscillation frequency of the member is anywhere from 50Hz to 300 Hz.

Optionally, the handheld device further includes a storage mediumconfigured to store information related to a treatment duration, atreatment start time, a treatment end time, an applied force, atreatment frequency, or any combination of the foregoing.

Optionally, the motor is configured to oscillate the member at theoscillation frequency to stimulate a nasal nerve to induce the tearproduction.

Optionally, the body portion comprises a nose region, and the secondportion of the member is configured to apply the mechanical vibration tothe nose region.

Optionally, the body portion comprises a facial region, and the secondportion of the member is configured to apply the mechanical vibration tothe facial region.

Optionally, the second portion of the member is configured for placementover an infraorbital nerve.

Optionally, the second portion of the member is configured for placementover an anterior ethmoidal nerve.

Optionally, the second portion of the member is configured for placementover an external nasal nerve.

Optionally, the second portion of the member is configured for placementover a nasociliary nerve.

Optionally, the second portion of the member is configured for placementover an eyelid or on a sclera of an eye.

Optionally, the second portion of the member is configured for placementalong a sensory portion of an ophthalmic nerve division of a trigeminalnerve.

Optionally, the second portion of the member is configured to apply avibrational force having a first directional component that isperpendicular to a surface of the body portion.

Optionally, the vibrational force has a second directional componentthat is parallel to the surface of the body portion.

Optionally, a first frequency of the first directional component ishigher than a second frequency of the second directional component.

Optionally, the second portion has a curvilinear surface for contactingthe body portion.

Optionally, the second portion has a convex exterior surface.

Optionally, the handheld device further includes a power switch operableby the individual to activate the handheld device.

Optionally, the power switch comprises a button, wherein the handhelddevice is configured to be activated in response to a pressing of thebutton, and is configured to be de-activated when the button isun-pressed.

Optionally, the second portion of the member is outside the housing.

Optionally, the housing comprises an opening, and the second portion ofthe member is configured to oscillate within the opening.

Optionally, the second portion has a thickness measured in a directionthat is parallel to a skin against which the second portion is to beapplied, the thickness being between 0.5 mm and 3 mm.

Optionally, the second portion has a tissue-contacting surface, a sidewall, and a dull corner between the tissue-contacting surface and theside wall.

A method to treat a dry eye condition of an individual, includes:receiving a switch signal generated based on a manipulation of a controlswitch at a handheld device; and activating a motor in response to theswitch signal to oscillate a member at an oscillation frequency, themember having an elongated configuration, and having a portion forplacement outside the individual; wherein the oscillation frequency issufficient to induce tear production when the portion of the member isapplied towards a surface of a body portion of the individual.

Optionally, the motor is activated to cause the member to undergobending action in a reciprocating manner.

Optionally, the member comprises a cantilevered beam having a free end,the portion being at the free end of the cantilevered beam.

Optionally, the motor is activated to cause the cantilevered beam toundergo bending action in a reciprocating manner.

Optionally, the method further includes varying a speed of the motor inresponse to an amount of force received at the portion of the member.

Optionally, the method further includes varying the oscillationfrequency of the member in response to an amount of force received atthe portion of the member.

Optionally, the method further includes receiving power from a powersource located in a housing of the handheld device.

Optionally, the power source is a rechargeable battery.

Optionally, the portion of the member oscillates with a substantiallyfixed amplitude in air.

Optionally, the substantially fixed amplitude is anywhere between 0.25mm and 1.5 mm.

Optionally, the portion of the member has a durometer that is anywherebetween 40A to 60A.

Optionally, the portion of the member oscillates with a force that isanywhere from 1 N to 3 N.

Optionally, the oscillation frequency of the member is anywhere from 50Hz to 300 Hz.

Optionally, the method further includes storing information related to atreatment duration, a treatment start time, a treatment end time, anapplied force, a treatment frequency, or any combination of theforegoing.

Optionally, the motor oscillates the member at the oscillation frequencyto stimulate a nasal nerve to induce the tear production.

Optionally, the body portion comprises a nose region.

Optionally, the body portion comprises a facial region.

Optionally, the portion of the member is configured for placement overan infraorbital nerve.

Optionally, the portion of the member is configured for placement overan anterior ethmoidal nerve.

Optionally, the portion of the member is configured for placement overan external nasal nerve.

Optionally, the portion has a curvilinear surface for contacting thebody portion.

Optionally, the portion has a convex exterior surface.

Optionally, the control switch comprises a button, wherein the switchsignal is generated in response to a pressing of the button, and whereinthe method further comprises de-activating the handheld device when thebutton is un-pressed.

Optionally, the portion of the member oscillates outside a housing ofthe handheld device.

Optionally, the handheld device has a housing with an opening, and theportion of the member oscillates within the opening.

A method to treat a dry eye condition of an individual, includes:receiving a switch signal generated based on a manipulation of a controlswitch at a handheld device; and activating a motor in response to theswitch signal to cause a member to undergo bending action in areciprocating manner to oscillate a portion of the member at anoscillation frequency, the member having a portion for placement outsidethe individual; wherein the oscillation frequency is sufficient toinduce tear production when the portion of the member is applied towarda surface of a body portion of the individual.

Optionally, the portion of the member is moveable into a housing inresponse to a force applied to the portion of the member.

Optionally, the member comprises a cantilevered beam having a free end,the portion being at the free end of the cantilevered beam.

Optionally, the member comprises a cantilevered beam having a fixed end,wherein the fixed end affects an oscillation property of thecantilevered beam.

Optionally, the method further includes varying a speed of the motor inresponse to an amount of force received at the portion of the member.

Optionally, the method further includes varying the oscillationfrequency of the member in response to an amount of force received atthe portion of the member.

Optionally, the method further includes receiving power from a powersource located in a housing of the handheld device.

Optionally, the power source is a rechargeable battery.

Optionally, the portion of the member oscillates with a substantiallyfixed amplitude in air.

Optionally, the substantially fixed amplitude is anywhere between 0.25mm and 1.5 mm.

Optionally, the portion of the member has a durometer that is anywherebetween 40A to 60A.

Optionally, the portion of the member oscillates with a force that isanywhere from 1 N to 3 N.

Optionally, the oscillation frequency of the member is anywhere from 50Hz to 300 Hz.

Optionally, the method further includes storing information related to atreatment duration, a treatment start time, a treatment end time, anapplied force, a treatment frequency, or any combination of theforegoing.

Optionally, the motor oscillates the member at the oscillation frequencyto stimulate a nasal nerve to induce the tear production.

Optionally, the body portion comprises a nose region.

Optionally, the body portion comprises a facial region.

Optionally, the portion of the member is configured for placement overan infraorbital nerve.

Optionally, the portion of the member is configured for placement overan eyelid or directly on a sclera of an eye.

Optionally, the portion of the member is configured to be insertedintranasally.

Optionally, the portion of the member is configured for placement alonga distribution of a sensory portion of an ophthalmic nerve division of atrigeminal nerve.

Optionally, the portion of the member is configured for placement overan anterior ethmoidal nerve.

Optionally, the portion has a curvilinear surface for contacting thebody portion.

Optionally, the portion has a convex exterior surface.

Optionally, the portion has a thickness that is anywhere from 0.5 mm to3 mm, and an edge forming an angle that is anywhere from 65 degrees to125 degrees.

Optionally, the control switch comprises a button, wherein the switchsignal is generated in response to a pressing of the button, and whereinthe method further comprises de-activating the handheld device when thebutton is un-pressed.

Optionally, the portion of the member oscillates outside a housing ofthe handheld device.

Optionally, the handheld device has a housing with an opening, and theportion of the member oscillates within the opening.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a member having a portion that is moveable relative to thehousing, wherein the portion of the member is configured to oscillate toapply the mechanical vibration to the body portion, the member having anelongated configuration; and a motor having a weight that is supportedby the member.

Optionally, the motor is fixedly attached to the member.

Optionally, the motor has a motor housing, and the motor housing isattached to the member.

Optionally, the motor comprises a shaft, and the handheld device furthercomprises an eccentric mass secured to a shaft of the motor.

Optionally, the motor and the portion of the member are configured tomove together.

Optionally, the handheld device further includes an electrical wireconnected to the motor, wherein at least a portion of the electricalwire is coupled to the member.

Optionally, the member has a first bending stiffness in a first bendingdirection, and a second bending stiffness in a second bending direction,the second bending stiffness being higher than the first bendingstiffness.

Optionally, the first bending direction corresponds with a direction ofoscillation by the portion of the member.

Optionally, the member has a cross section with a first side and asecond side, the first side being longer than the second side, andwherein the motor is attached to the first side.

Optionally, the motor configured to oscillate the member at anoscillation frequency sufficient to induce tear production or a sinuseffect when the portion of the member is applied towards a surface ofthe body portion.

Optionally, the motor is configured to cause the member to undergobending action in a reciprocating manner.

Optionally, the member comprises a cantilevered beam having a free end,the portion of the member being at the free end of the cantileveredbeam.

Optionally, the motor is configured to cause the cantilevered beam toundergo bending action in a reciprocating manner.

Optionally, the handheld device further includes a power sourceaccommodated in the housing.

Optionally, the portion of the member is configured to oscillate with anamplitude that is anywhere between 0.25 mm and 1.5 mm.

Optionally, the portion of the member has a durometer that is anywherebetween 40A to 60A.

Optionally, the portion of the member is configured to oscillate with aforce that is anywhere from 1 N to 3 N.

Optionally, an oscillation frequency of the member is anywhere from 50Hz to 300 Hz.

Optionally, the handheld device further includes a storage mediumconfigured to store information related to a treatment duration, atreatment start time, a treatment end time, an applied force, atreatment frequency, or any combination of the foregoing.

Optionally, the motor is configured to oscillate the member at anoscillation frequency sufficient to stimulate a nasal nerve to inducethe tear production.

Optionally, the body portion comprises a nose region, and the portion ofthe member is configured to apply the mechanical vibration to the noseregion.

Optionally, the body portion comprises a facial region, and the portionof the member is configured to apply the mechanical vibration to thefacial region.

Optionally, the portion of the member is configured for placement overan infraorbital nerve.

Optionally, the portion of the member is configured for placement overan anterior ethmoidal nerve.

Optionally, the portion of the member is configured for placement overan external nasal nerve.

Optionally, the portion of the member is configured for placement overan eyelid or on a sclera of an eye.

Optionally, the portion of the member is configured for placement alonga sensory portion of an ophthalmic nerve division of a trigeminal nerve.

Optionally, the portion of the member is configured for placement insidea nasal opening.

Optionally, the portion of the member is configured to apply avibrational force having a first directional component that isperpendicular to a surface of the body portion.

Optionally, the vibrational force has a second directional componentthat is parallel to the surface of the body portion.

Optionally, the portion of the member has a curvilinear surface forcontacting the body portion.

Optionally, the portion of the member has a convex exterior surface.

Optionally, the handheld device further includes a power switch operableby the individual to activate the handheld device.

Optionally, the power switch comprises a button, wherein the handhelddevice is configured to be activated in response to a pressing of thebutton, and is configured to be de-activated when the button isun-pressed.

Optionally, the portion of the member is outside the housing.

Optionally, the housing comprises an opening, and the portion of themember is configured to oscillate within the opening.

Optionally, the portion of the member has a thickness measured in adirection that is parallel to a skin against which the portion of themember is to be applied, the thickness being between 0.5 mm and 3 mm.

Optionally, the portion of the member has a tissue-contacting surface, aside wall, and a dull corner between the tissue-contacting surface andthe side wall.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a member having a portion that is moveable relative to thehousing, wherein the portion of the member is configured to oscillate toapply the mechanical vibration to the body portion, the member having anelongated configuration; and a motor having a motor housing that isfixed in position with respect to the member, and wherein the motor andthe member are configured to move relative to the housing together asone unit.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a member having a portion that is moveable relative to thehousing, wherein the portion of the member is configured to oscillate toapply the mechanical vibration to the body portion, the member having anelongated configuration; and a motor carried by the member.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a member having an exterior surface for contacting theindividual, the member configured to oscillate to apply the mechanicalvibration to the body portion; and a motor in the housing, the motorconfigured to cause the member to oscillate at an oscillation frequencyfor inducing tear production or a sinus effect; wherein the handhelddevice has an operational sound level that is 40 dB or less.

Optionally, the motor is configured to cause the member to oscillatewithout using mechanical linkage to move the member relative to themotor, thereby allowing the handheld device to have the operationalsound level that is 40 dB or less.

Optionally, the motor has a weight that is supported by the member.

Optionally, the motor is fixedly attached to the member.

Optionally, the motor has a motor housing, and the motor housing isattached to the member.

Optionally, the motor comprises a shaft, and the handheld device furthercomprises an eccentric mass secured to a shaft of the motor.

Optionally, the motor and a portion of the member are configured to movetogether.

Optionally, the handheld device further includes an electrical wireconnected to the motor, wherein at least a portion of the electricalwire is coupled to the member.

Optionally, the member has a first bending stiffness in a first bendingdirection, and a second bending stiffness in a second bending direction,the second bending stiffness being higher than the first bendingstiffness.

Optionally, the first bending direction corresponds with a direction ofoscillation by the member.

Optionally, the member has a cross section with a first side and asecond side, the first side being longer than the second side, andwherein the motor is attached to the first side.

Optionally, the motor is configured to cause the member to undergobending action in a reciprocating manner.

Optionally, the member comprises a cantilevered beam having a free end,the exterior surface being at the free end of the cantilevered beam.

Optionally, the motor is configured to cause the cantilevered beam toundergo bending action in a reciprocating manner.

Optionally, a speed of the motor is variable based on an amount of forceapplied at the exterior surface.

Optionally, the oscillation frequency of the member is variable based onan amount of force applied at the exterior surface.

Optionally, the handheld device further includes a power sourceaccommodated in the housing.

Optionally, the handheld device further includes a port configured toreceive an adapter for charging the power source.

Optionally, the power source is a rechargeable battery.

Optionally, the member is configured to oscillate with an amplitude thatis anywhere between 0.25 mm and 1.5 mm.

Optionally, the member has a durometer that is anywhere between 40A to60A.

Optionally, the member is configured to oscillate with a force that isanywhere from 1 N to 3 N.

Optionally, the oscillation frequency of the member is anywhere from 50Hz to 300 Hz.

Optionally, the handheld device further includes a storage mediumconfigured to store information related to a treatment duration, atreatment start time, a treatment end time, an applied force, atreatment frequency, or any combination of the foregoing.

Optionally, the motor is configured to oscillate the member at theoscillation frequency to stimulate a nasal nerve.

Optionally, the body portion comprises a nose region, and the member isconfigured to apply the mechanical vibration to the nose region.

Optionally, the body portion comprises a facial region, and the memberis configured to apply the mechanical vibration to the facial region.

Optionally, a portion of the member is configured for placement over aninfraorbital nerve.

Optionally, a portion of the member is configured for placement over ananterior ethmoidal nerve.

Optionally, a portion of the member is configured for placement over anexternal nasal nerve.

Optionally, a portion of the member is configured for placement over aneyelid or on a sclera of an eye.

Optionally, a portion of the member is configured for placement along asensory portion of an ophthalmic nerve division of a trigeminal nerve.

Optionally, a portion of the member is configured for placement inside anasal opening.

Optionally, the exterior surface has a curvilinear surface.

Optionally, the exterior surface has a convex configuration.

Optionally, the convex configuration of the exterior surface allows anarea of contact with the individual to be adjustable.

Optionally, the exterior surface has a convex exterior surface.

Optionally, the handheld device further includes a power switch operableby the individual to activate the handheld device.

Optionally, the power switch comprises a button, wherein the handhelddevice is configured to be activated in response to a pressing of thebutton, and is configured to be de-activated when the button isun-pressed.

Optionally, the member has a portion located inside the housing.

Optionally, the housing comprises an opening, and the member isconfigured to oscillate within the opening.

Optionally, the member is configured to be selectively placed on eithera right side or a left side of the individual.

Optionally, the housing comprises an opening, wherein the member isconfigured to oscillate within the opening, and wherein the member isconfigured to elastically retract into the housing with a springconstant in response to external force applied against the member.

Optionally, the member is configured to simultaneously apply themechanical vibration to a right side and a left side of the individual.

Optionally, a portion of the member has a thickness measured in adirection that is parallel to a skin against which the second portion isto be applied, the thickness being between 0.5 mm and 3 mm.

Optionally, a portion of the member has a tissue-contacting surface, aside wall, and a dull corner between the tissue-contacting surface andthe side wall.

A method to treat a condition of an individual, includes: receiving aswitch signal generated based on a manipulation of a control switch at ahandheld device; and activating a motor in response to the switch signalto oscillate a member at an oscillation frequency; wherein theoscillation frequency is sufficient to induce tear production or a sinuseffect when the portion of the member is applied towards a body portionof the individual; and wherein the handheld device generates sound thatis less than 40 dB when the member oscillates.

Optionally, the motor causes the member to oscillate without usingmechanical linkage to move the member relative to the motor, therebyallowing the handheld device to have the operational sound level that is40 dB or less.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a member having an exterior surface for contacting theindividual, the member configured to oscillate to apply the mechanicalvibration to the body portion; and a motor in the housing, the motorconfigured to cause the member to oscillate at an oscillation frequencyfor inducing tear production or a sinus effect; wherein the motor isconfigured to cause the member to oscillate without using mechanicallinkage to move the member relative to the motor, thereby allowing thehandheld device to have an operational sound level that is 40 dB orless.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a cantilever beam having a first portion accommodated in thehousing, and a second portion that is moveable relative to the housing,wherein the second portion is configured to apply the mechanicalvibration to the body portion; and a motor in the housing, the motorconfigured to oscillate the second portion of the cantilever beam at anoscillation frequency.

Optionally, the motor is fixedly attached to the cantilever beam.

Optionally, the motor has a motor housing, and the motor housing isattached to the cantilever beam.

Optionally, the motor comprises a shaft, and the handheld device furthercomprises an eccentric mass secured to a shaft of the motor.

Optionally, the motor and the second portion of the cantilever beam areconfigured to move together.

Optionally, the handheld device further includes an electrical wireconnected to the motor, wherein at least a portion of the electricalwire is coupled to the cantilever beam.

Optionally, the cantilever beam has a first bending stiffness in a firstbending direction, and a second bending stiffness in a second bendingdirection, the second bending stiffness being higher than the firstbending stiffness.

Optionally, the first bending direction corresponds with a direction ofoscillation by the second portion of the cantilever beam.

Optionally, the cantilever beam has a cross section with a first sideand a second side, the first side having a larger dimension than thesecond side, and wherein the motor is attached to the first side.

Optionally, the motor configured to oscillate the cantilever beam at anoscillation frequency sufficient to induce tear production or a sinuseffect when the second portion of the cantilever beam is applied towardsa surface of the body portion.

Optionally, the motor is configured to cause the cantilever beam toundergo bending action in a reciprocating manner.

Optionally, the cantilever beam has a free end, the second portion beingat the free end of the cantilever beam.

Optionally, the cantilever beam has a fixed end, the first portion beingat the fixed end of the cantilever beam.

Optionally, the second portion of the cantilever beam is configured tooscillate with an amplitude that is anywhere between 0.25 mm and 1.5 mm.

Optionally, the second portion of the cantilever beam has a durometerthat is anywhere between 40A to 60A.

Optionally, the second portion of the cantilever beam is configured tooscillate with a force that is anywhere from 1 N to 3 N in free air.

Optionally, an oscillation frequency of the cantilever beam is anywherefrom 50 Hz to 300 Hz.

Optionally, an oscillation frequency of the cantilever beam is anywherefrom 200 Hz to 300 Hz.

Optionally, the handheld device further includes a storage mediumconfigured to store information related to a treatment duration, atreatment start time, a treatment end time, an applied force, atreatment frequency, or any combination of the foregoing, and whereinthe information is for tailoring a patient specific treatment.

Optionally, the motor is configured to oscillate the second portion ofthe cantilever beam at an oscillation frequency sufficient to stimulatea nerve to induce the tear production.

Optionally, the body portion comprises a nose region, and the secondportion of the cantilever beam is configured to apply the mechanicalvibration to the nose region.

Optionally, the body portion comprises a facial region, and the secondportion of the cantilever beam is configured to apply the mechanicalvibration to the facial region.

Optionally, the second portion of the cantilever beam is configured forplacement over an infraorbital nerve.

Optionally, the second portion of the cantilever beam is configured forplacement over an anterior ethmoidal nerve.

Optionally, the second portion of the cantilever beam is configured forplacement over an external nasal nerve.

Optionally, the second portion of the cantilever beam is configured forplacement over an eyelid or on a sclera of an eye.

Optionally, the second portion of the cantilever beam is configured forplacement along a sensory portion of an ophthalmic nerve division of atrigeminal nerve.

Optionally, the second portion of the cantilever beam is configured forplacement along a maxillary portion of an ophthalmic nerve.

Optionally, the second portion of the cantilever beam is configured forplacement inside a nasal opening.

Optionally, the second portion of the cantilever beam is configured toapply a vibrational force having a first directional component that isperpendicular to a surface of the body portion.

Optionally, the vibrational force has a second directional componentthat is parallel to the surface of the body portion.

Optionally, the second portion has a curvilinear surface for contactingthe body portion.

Optionally, the second portion has a convex exterior surface.

Optionally, the handheld device further includes a power switch operableby the individual to activate the handheld device, wherein the powerswitch comprises a button, wherein the handheld device is configured tobe activated in response to a pressing of the button, and is configuredto be de-activated when the button is un-pressed.

Optionally, the second portion has a thickness measured in a directionthat is parallel to a skin against which the second portion is to beapplied, the thickness being between 0.5 mm and 3 mm.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a cantilever beam having a first portion accommodated in thehousing, and a second portion that is moveable relative to the housing,wherein the second portion is configured to apply the mechanicalvibration to the body portion; and a motor in the housing, wherein themotor and the second portion of the cantilever beam are configured tomove together.

Optionally, the motor has a motor housing, and the motor housing isattached to the cantilever beam.

Optionally, the motor comprises a shaft, and the handheld device furthercomprises an eccentric mass secured to a shaft of the motor.

A handheld device for applying mechanical vibration to a body portion ofan individual to treat a condition of the individual, includes: ahousing; a cantilever beam having a first portion accommodated in thehousing, and a second portion that is moveable relative to the housing,wherein the second portion is configured to apply the mechanicalvibration to the body portion; and a motor in the housing, wherein themotor has a motor housing, and the motor housing is attached to thecantilever beam.

Optionally, the motor comprises a shaft, and the handheld device furthercomprises an eccentric mass secured to a shaft of the motor.

Other features and aspects will be described in the detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features are set forth with particularity in the appendedclauses. A better understanding of the features and advantages will beobtained by reference to the following detailed description that setsforth illustrative embodiments and the accompanying drawings of which:

FIG. 1 depicts a tear duct with inspissated material.

FIG. 2 depicts a device to deliver vibrational energy to the nasalturbinates and nerves inside the nasal cavity via contact through theskin and bony structures of the nose.

FIG. 3 depicts a coronal section through the sinuses

FIG. 4 depicts a coronal section through the face with the tear ductanatomy outlined.

FIG. 5 illustrates an ultrasound transducer adapted to apply ultrasoundenergy to the tissues of the nasal cavity.

FIG. 6 depicts the interface between an ultrasound device and thetissues of the face.

FIG. 7 depicts a coronal view of the sinuses.

FIG. 8 depicts an assembly schematic for a device to apply vibratingenergy to nerve trigger points on a face.

FIG. 9 depicts the boney and soft tissue structures in and around thenose.

FIG. 10 depicts the nerve anatomy in and around the nose.

FIG. 11 depicts an embodiment of a handheld tear stimulator.

FIG. 12 depicts an expanded view of a handheld neurostimulator to createtears.

FIG. 13 depicts an expanded view of a neurostimulator device.

FIG. 14 depicts an expanded view of another neurostimulator device.

FIG. 15 depicts a device which applies mechanical vibration bilaterallyto a patient.

FIG. 16 depicts the device in FIG. 15 in more detail.

FIG. 17 depicts the inner mechanism of a device to create tears in apatient.

FIG. 18 depicts a device which generates linear vibratory motion to beapplied to the skin or eye of a patient.

FIG. 19A depicts a carpal ligament and median nerve of a wrist.

FIG. 19B depicts a transverse section of a wrist.

FIG. 20 depicts various mechanisms through which a pore becomes plugged.

FIG. 21 depicts another embodiment of a device which generates vibratorymotion to be applied to the skin or eye of a patient.

FIG. 22 depicts the device of FIG. 21 being applied to the junction ofthe nasal bone and the anterior lateral nasal cartilage

FIG. 23 is a schematic representation of one embodiment of the device ofFIG. 21 .

FIG. 24 depicts a cross-sectional view of one embodiment of the deviceof FIG. 21 .

FIG. 25 depicts various dimensions of the device of FIG. 21 .

FIG. 26 depicts another embodiment of a device which generates vibratorymotion to be applied to an eye structure (e.g., lid, eyeball, etc.) of apatient.

FIG. 27 depicts a test fixture for testing a device which generatesvibratory motion.

FIG. 28A depicts a frequency and amplitude of an effector tip of adevice with one embodiment of a cantilever beam.

FIG. 28B depicts a frequency and amplitude of an effector tip of adevice with another embodiment of a cantilever beam.

FIG. 29A depicts a side view of an end effector of a clinicallyeffective device according to Table 1.

FIG. 29B depicts a top view of an end effector of a clinically effectivedevice according to Table 1.

FIG. 30A depicts a side view of an end effector of a clinicallyineffective device according to Table 1.

FIG. 30B depicts a top view of an end effector of a clinicallyineffective device according to Table 1.

FIG. 31 depicts equations for calculating natural frequency of acantilever beam.

DETAILED DESCRIPTION

Various embodiments are described hereinafter with reference to thefigures. It should be noted that the figures are not drawn to scale andthat elements of similar structures or functions are represented by likereference numerals throughout the figures. It should also be noted thatthe figures are only intended to facilitate the description of theembodiments. They are not intended as an exhaustive description of theinvention or as a limitation on the scope of the invention. In addition,an illustrated embodiment needs not have all the aspects or advantagesshown. An aspect or an advantage described in conjunction with aparticular embodiment is not necessarily limited to that embodiment andcan be practiced in any other embodiments even if not so illustrated, orif not so explicitly described.

One or more of the embodiments described herein pertain to utilizingmechanical force to treat disorders of the eye including disorders ofthe front of the eye and the back of the eye.

Sound, ultrasound, and vibration are utilized interchangeably in thisdisclosure. Mechanical vibration at audible frequencies (20 to 20,000Hz) may or may not actually transmit audible sound waves but maytransmit force to a surface and is included in the broad definition ofsound and ultrasound. Vibration, or mechanical vibration, is thebroadest term and encompasses all sound or ultrasound regardless ofwhether pressure waves are created. Sound is simply mechanical vibrationwhich transmits pressure waves through a medium which is then processedand “heard.” Vibration as a category encompasses ultrasound and sound aswell as mechanical vibration which may not result in sound. For example,mechanical vibration may be delivered by a probe with a linear motion, aplanar motion, or motion in all three axes. The important aspect ofmechanical vibration is the motion and a frequency of at least a fewHertz (Hz). The underlying mechanism of purposeful vibration (as opposedto unwanted vibration created incidentally to another mechanism such asa running motor) is to and from motion intentionally created by a movingmechanism along with transduction to another medium, for example, a bodytissue of a human subject. The motion of the vibration can be created bya number of different mechanisms including motors with a gear andcamshaft to create an offset, an eccentric motor, a linear resonantactuator, a voice coil, and a piezoelectric mechanism. In this respect,mechanical vibration is easier to create than sound.

The frequency of the sound waves may range from the low frequency subaudible range to the higher frequency inaudible ultrasound range.Devices described herein treat dry eye by increasing the amount of tearsin the eye or treat congestion by activating nerves in the nose region.These devices act synergistically with devices which improve the qualityof the tear film. These devices create tears by activating thesphenopalatine ganglion (indirectly or directly) and/or facial nervebranches, and/or ethmoidal nerves with ultrasound or sound or mechanicalvibration externally applied through the skin of the nose. An example ofa direct stimulation of the sphenopalatine ganglia is throughstimulation of the ganglia itself. An example of indirect stimulation ofthe sphenopalatine ganglia is through activation of a sensory pathwaywhich then communicates via reflex neural circuit to the sphenopalatineganglia to increase output or tears. Another embodiment can treat avariety of disorders utilizing sound and/or ultrasound and/or vibrationwhich is externally applied to the skin of the head and neck andactivates nerves or nerve ganglia under the skin. Another embodimentapplies vibratory energy to the mucosa inside of the nose or to themucosa on the inside of the eyelids to treat dry eye.

The nasolacrimal apparatus is the physiological system containing theorbital structures for tear production and drainage. It consists of thelacrimal gland, the lacrimal canaliculi, and the nasolacrimal duct whichcommunicates with the cavity of the nose. The innervation of thelacrimal apparatus involves both the sympathetic supply through thecarotid plexus of nerves around the internal carotid artery, andparasympathetically from the lacrimal nucleus of the facial nerve in thebrainstem. Signals travel from sensory (afferent) fibers around the faceto the area of the salivary nucleus in the brainstem to activate theparasympathetic fibers which travel back to the sphenopalatine gangliato synapse and then send terminal nerve fibers to innervate the lacrimalgland.

As shown in FIG. 1 , tear ducts 130 may contain inspissated oils, or maybe otherwise blocked with material 135 preventing tears or tearcomponents (e.g. oils, lipids, etc.) from being excreted into the tearfilm of the eye. In one example, a disease which is treated by themethods and devices described herein is dry eye.

In another embodiment, eyelash growth is stimulated with mechanicalvibration. For example, it has been shown in previous models in bonetissue that ultrasound delivered at 50 kHz and 1 MHz stimulatesprostaglandin release (Bone 2002 Jul 31; 236-41). Prostaglandin releasehas been considered the main mechanism of action for the pharmaceuticalagent bimatoprost, an FDA approved agent to stimulate eye lash growth.Therefore, in one embodiment, a vibratory stimuli is utilized toupregulate prostaglandin synthesis and increase thickness of eyelashesin a subject. Indeed, any of the embodiments herein may be combined withpharmaceuticals.

Ultrasound, sound, or vibration can be used to heat and/or vibrate thematerial 135 to remove it from the duct 130, as shown in FIG. 1 . Insome embodiments, the ultrasound frequency chosen is one which resonatesat the interface of the duct and the inspissated material to dislodge orheat the material in the duct so that the secretions from the duct canreach the eye and prevent dry eye. For example, early work has shownthat sound frequencies in the 100 Hz to 500 Hz range will lead to breakup of the material in the inspissated ducts. When combined with higherfrequency ultrasound energy (e.g. 1 MHz to 3 MHz), the material can beheated to improve the efficiency of the unblocking of the ducts. In someembodiments, temperature measurement is utilized to facilitate thesafety and efficacy of the treatment; a temperature range of between 40and 48° C. is the preferred temperature. The temperature can becontrolled with closed loop control in which a thermistor is utilized tomeasure temperature and then the feedback through a control circuit isutilized to control the power output so as to maintain the temperaturein a pre-specified range.

FIG. 2 depicts an embodiment of a device to stimulate the lacrimal glandor other nerves or ganglia transcutaneously through the skin to thenerves and ganglia. Regions 2012, 2014, and 2010 have been shownexperimentally to produce the greatest amount of nerve stimulation byway of vibration of the facial bones which in turn stimulate the nervessuch as sphenopalatine ganglia, lacrimal nerve, external nasal nerve,infratrochlear nerve, supratraochlear nerve, infraorbital nerve,supraorbital nerve etc. For example, region 2012, when exposed to directskin vibration at approximately 100 Hz - 300 Hz vibration producescopious bilateral tear formation and relieves congestion when just asingle side is stimulated. In some embodiments, vibrations from about 50Hz to about 500 Hz are utilized to stimulate the bones of the face to,in turn, transmit vibrations to the nerves which stimulate tearproduction. The treatment works best at the resonant frequency of thebone so that the vibration of the bone is maximal and affects the nervemaximally due to the greatest amount of mechanical movement of the nerveand subsequent stimulation. The resonant frequency of the bone is tosome extent individualized per patient. This frequency has beenexperimentally determined and subsequently proven to be in the range ofabout 100-300 Hz.

Region 2014 (FIG. 2 ) includes the bottom eyelid (inner and outereyelid), the medial canthus of the eye along the nasolacrimal duct.External stimulation along these regions in some embodiments stimulatesthe nerves through bony resonance and, in some embodiments, stimulatesthe glands in the lower eyelid region directly.

FIG. 3 depicts neural pathways involved in the transduction of vibrationfrom the skin to the lacrimal gland when vibrations are applied throughthe preferred external location 2012 in FIG. 2 . Ganglia 2520 projectsnerves to the lacrimal nerve 2550 which courses to the orbit tostimulate the main lacrimal gland in the superior portion of the orbit.Bone 2530 transmits vibrations to the lacrimal nerve 2550 and around themaxillary sinus 2500 via the sphenopalatine ganglia. The sphenopalatineganglia 2520 is covered by mucosa and sits between the turbinates whichare accessible transnasally through the external nasal passageways 2510.The external nasal nerve is a terminal branch of the ophthalmic branchof the trigeminal nerve and is directly stimulated with vibration as itis compressed against its exit from underneath the nasal bone at thejunction of the nasal bone and the anterior lateral nasal cartilage. Inanother embodiment, an ultrasound or sound producing probe is insertedthrough the external nasal passageways 2510 and applied to the mucosa inproximity to the sphenopalatine ganglia 2520 to stimulate tearproduction through direct stimulation or via the nasolacrimal reflex. Inanother embodiment, a vibratory probe with vibration at approximately100-300 Hz is inserted into the nasal passage to directly stimulate thesphenopalatine ganglia and/or the interior anterior ethmoidal nerves onthe interior of the nasal passage. In another embodiment, electricalstimulation of the external nasal nerve accomplishes tearing byactivating the lacrimal nucleus in the pons and subsequentlypre-gangliotic fibers within the maxillary nerve which synapse in thesphenopalatine ganglia and then stimulate the lacrimal nerve to producetears.

In one embodiment, a method to stimulate neural pathways through theapplication of sound or ultrasound energy transcutaneously is described.An applicator is disposed to the face of the patient, the applicatorcomprising one or more vibratory elements capable of generatingvibrations from about 50 Hz to about 50 kHz. The vibration is applied toa region close to a nerve under the skin or to a region with a bonyprominence which communicates via bone structure with a nerve regionlocated close to the skin. For example, an applicator 2000 disposed tothe region 2010, 2012 (FIG. 2 ) or 2014 (FIGS. 2, 4 ) will transmit thevibratory energy to the lacrimal glands and produce tears. The resonantfrequency is different for each person as is the exact location anddirection of the vibration. In one embodiment, the individual resonantfrequency is determined and the device adjusted to this frequency foreach person. An interface between the device and the patient’s skin issimilarly adjustable so that the vibrations are transmitted to thenerves in the head and neck region to be stimulated. For example, theparasympathetic nerve which innervates the lacrimal gland travels withinthe maxillary bone and the sphenopalatine ganglia is located close tothe maxillary bone in the sphenopalatine fossa. At a resonant frequencyof the maxillary bone, it has been discovered that the ganglia can bestimulated and tears produced. The resonant frequency is achievedthrough a combination of material, vibration frequency, and amplitude.For example, a material with a durometer between Shore A40 and Shore A60vibrating over a surface area of between 5 mm² and 20 mm² with anamplitude of about 0.5 to 5 mm and frequency of between 50 Hz and 400 Hzresults in copious tears. With a directionality upward and at a locationapproximately along the nasal bone where it meets the cartilage, tearscan be produced without discomfort or sneezing or other nasal symptoms.The total force applied over the surface area in some embodiments isabout 1 N (Newton). In other embodiments, the total force is from about0.5 N to bout 2 N. In other embodiments, the force is about 0.25 N toabout 4 N.

In some embodiments, the device is connected to an iTEAR application ona smart phone. For example, the device communicates with a smart phonethrough a Bluetooth application or via wifi. The application on thesmart phone might track usage of the device, the force applied to thecantilever of the device, the remaining power charge, the and thefrequency of the device. In one embodiment, the application on the smartdevice takes a picture of the eye or eyes of the patient during thestimulation of the lacrimal glands. A subsequent or sequential set ofimages are compared to one another and the thickness of the tear filmdetermined. The change in the tear film is determined based on areflectance from the tear film as the result of a camera flash.Alternatively, a filter is utilized to determine the difference betweenpre-stimulation and post-stimulation. A custom light source can bedriven by the smart device and the reflected light collected by thedevice. For example, an infrared, red, or blue light source can be hardwired to the device. A baseline picture is obtained and stimulationbegun. The light is projected to the tear film and the tear filmquantified through a series of baseline and during treatment picturesare obtained. In one embodiment, interferometry is obtained after thelight is applied to the tear film.

FIG. 9 depicts the bony anatomy of the face. FIG. 10 depicts the nervousanatomy of the face. In FIG. 10 , at the point where the upper lateralcartilage meets the nasal bone, the external branch of the anteriorethmoidal nerve penetrates the nasal bone is depicted. This location iswhere the lateral process of the septal nasal cartilage meets the nasalbone (FIG. 9 ) and 2012 in FIG. 5 . This is the location, located on theskin, which has been discovered through experimentation to produce tearswhen mechanical vibration is applied at a frequency of 50-300 Hz with avibration amplitude of approximately 0.5 mm to 1.5 mm and/or force ofabout 0.5 to 1.5 N.

Furthermore, it has been discovered that direct stimulation of theinfratrochlear and infraorbital nerves with mechanical vibration alsoinduces lacrimation. Mechanical vibration can also stimulate lacrimationby direct contact with the mucosal surfaces inside the nose.

FIG. 10 depicts the neural anatomy of this region underneath the skin.The anterior ethmoidal nerve, a direct continuation of the nasociliarynerve, splits into two branches to supply the nasal mucosa, medial andlateral, as it enters the nasal cavity where is supplies the nasalmucosa. The nasociliary nerve continues to the caudal region of thenasal bone and appears 6.5 mm to 8.5 mm from the midline as the externalnasal nerve The infraorbital nerve 5010 exits the bone and travels intothe skin approximately 1-2 cm below the lower eyelid. It is the externalnasal nerve which has been determined to induce tearing when vibrationsat 50-300 Hz are applied. Electrical stimulation (bipolar or monopolar)of the external nasal nerve in this region also can be utilized toinduce lacrimation.

A well described pathway for lacrimation is called the nasolacrimalreflex in which stimulation of afferent fibers of the anterior ethmoidalnerve (accessible inside the nose) travel through the ophthalmic nerveto the salivary nucleus in the brain stem, then parasympathetic nervesignals travel via the maxillary branch of the trigeminal synapse in thesphenopalatine ganglia to innervate the lacrimal nerve and stimulate thelacrimal glands. Parasympathetic fibers generally stimulate the lacrimalglands and also partially innervate the Meibomian glands.

In addition to the specific descriptions set forth herein, it has beendiscovered through extensive experimentation that stimulation of theexternal nasal nerve achieves lacrimation. As described above, theexternal nasal nerve 5020 exits to the surfaceof the skin from deep tothe layers of the skin through an orifice at the junction of the nasalcartilage and nasal bone. It is not accessible by electricalstimulation. As described herein, certain vibrational parameters resultin stimulation of lacrimation similar to the nasolacrimal reflex.

The external nasal nerve is a continuation of the nasociliary nervewhich originates from the ophthalmic branch of the trigeminal nerve.Prior to its exit from the inner portion of the nose to the externalportion of the nose, it gives off two branches to the inner portion ofthe nose. The external nasal branch is the terminal nerve of thenasociliary nerve. After exiting the inner portion of the nose betweenthe nasal bone and the upper lateral cartilage (through a notch in thenasal bone), the external nasal nerve dips into the fibrofatty tissue toultimately branch and supply the skin and fatty tissues of the distalnose. In an anatomic study, the exit of the nerve was consistently 6.5 –8.5 mm lateral to the nasal midline independent of the width of nose.There were three branching patterns identified. The first was a singlenerve exiting the nasal bone. The second pattern was splitting of thenerve upon exit from the nasal bone, and the third pattern was splittingof the nerve distal to the exit from the nasal bone close to thecartilage of the distal region of the nose. The nerve size in this studywas consistently 0.3 mm to 0.4 mm diameter.

Therefore, in one embodiment, a device is placed approximately 6.5 to8.5 mm lateral to the nasal midline at the region where the upperlateral cartilage meets the nasal bone. The device is placedunilaterally or bilaterally or unilaterally and then sequentially on thecontralateral side for bilateral treatment. The device applies a forceover an area of 1-2 mm² on the nose at frequency of 100-300 Hz. In someembodiments, approximately 0.5 to about 2.0 N of force is applied to theexternal nasal nerve as it leaves the nasal bone. In other embodiments,a force of approximately 2 to about 5 N is applied to the nose toactivate the external nasal nerve. Despite extensive anatomicdescriptions, until the current invention, there has been no descriptionof the function of the nerve beyond the sensory distribution to the skinof the nose.

In another embodiment in FIG. 4 , the nasolacrimal duct is the target.It has been found in clinical work that stimulation of this ductinternally along its length leads to stimulation of tear production. Themechanism is thought to be direct stimulation of the nasolacrimalreflex. It has been further discovered that vibration at 100-500 Hzexternally through the skin in the region of the bone through which theduct travels (e.g. nasal bone) also stimulates this reflex. Similar tothe external nasal nerve, electrical stimulation has been found to beineffective in the stimulation of the reflex through this anatomy

The effector interface with the face of the patient is a very importantcomponent of the energy transmission to promote safety and tolerabilityof the procedure. Through experimentation, the optimal durometer issomewhere between Shore 40A (pencil eraser) and Shore 80A (leather).Shore 60A is about a car tire tread and Shore 70A is a running shoesole. With an interface which is too hard, the skin is abraded and withan interface which is too soft, the nerve is not effectively stimulated.

It has been determined that unfocused vibration at 50 Hz to about 300 Hzleads to general activation of the sphenopalatine ganglion, lacrimalnerve, external nasal nerve, infratrochlear nerve, infraorbital nerve,supraorbital nerve, or internal nasal nerve leading to inhibition ofrhinitis like symptoms by overstimulation and/or relief from nasalcongestion, migraines, narcolepsy, dry mouth, dry eye, and elevatedintra-ocular pressure via neuromodulation. Focused, or directedvibration, be it sound in which the vibrating waves are directed towardthe skin and bone by way of positioning the probe toward thenasopalatine ganglia, external nasal nerves, or eyelids, or lacrimalnerves have been determined to be more effective in eliciting specificpathways such as lacrimation.

FIG. 5 depicts a device usable to activate the lacrimation pathway byapplying vibration to the side of the nose and/or lacrimal pathway toactivate the external nasal nerve as it exits the nasal bone onto theskin of the nose. Vibratory energy at 100-300 Hz with 1 mm excursion and1-4 N of force stimulates the external nasal nerve when the energy isapplied to the region with a sufficiently rigid biocompatible material.

In another preferred embodiment, the vibration is applied directly tothe conjunctival region of the eyelid to stimulate tears directly bystimulating the accessory lacrimal glands in the lower lid and the smallmuscles that surround each of the Meibomian glands.

In one embodiment, the end effector of device 2000 is applied directlyto the lacrimal gland 2100 or to the mucosa of the inner eyelid. Device2000 is configured in one embodiment to run along the inner eyelid whilethe eyelid is being retracted to create tears, stimulate Meibomianglands, etc.

Therefore, in one embodiment, a vibratory device is applied to theskin/mucosa of the inner eyelid, applying an end effector moving atabout 50-300 Hz with the end effector moving approximately 250 micronsto 2 mm in excursion with 0.5 to 2 N of force, the end effector having abiocompatible material with durometer between about 60A and 100A and atip which applies the force to the skin over an area of about 1 mm² to 5mm². Pulsed frequencies (on-off) can enhance the effect. For example,the vibration can be applied with a 50% duty cycle or a 25% duty cyclewith a peak amplitude greater than the base amplitude. In oneembodiment, device 2000 is depressed against the skin of the nose in theregion where the nasal cartilage meets the nasal bone (aka the nasalala) 2012 where the cartilage and nasal bone meet along the side of thenose of the patient at the region where the external nasal nerve exitsthe nasal bone.

FIG. 6 depicts the structural details of the ultrasound transmissionfrom the skin through the bone and to the nerves which lie beneath thebones of the face. The end effector 2004 of the device 2002 communicateswith the skin 2050 and from there, the vibrations travel through theskin 2050 to the bone 2052 and to the mucous layer 2054 underneath. Fromthe bone, the vibration can be transmitted to the nerves in otherregions of the face such as the sphenopalatine ganglia, the infraorbitalnerve, the orbital nerve, the facial nerve, the trigeminal nerve, theethmoidal nerve, and ultimately, the lacrimal nerve.

Direct stimulation of the mucous layer through bone also will accomplishdirect treatment of sinus disease in addition to its effect on thenerves. Vibration and/or ultrasound stimulation of the mucosal layerswill affect congestion directly by unplugging the outflow pathways andequalizing pressure.

FIG. 7 depicts several of the bony pathways which can communicate withnerve pathways via neuroacoustic conduction present inside the cranium2150 and facial bones. The maxillary sinus and bone 2170 are thepredominant pathway for transmission of vibratory energy to thesphenopalatine ganglia and ultimately the lacrimal nerve and gland. Theconchae 2195 are folds of the maxillary bone which protrude partiallyinto the nasal cavity. The conchae protect the olfactory bulb as well asthe sphenopalatine ganglia but also play a role in transmission ofsounds. The maxillary bone and its conchae communicate with thezygomatic bone 2190. The inferior turbinates 2160 are covered withrespiratory mucosa. The sphenopalatine ganglia sits behind the inferiorturbinates. The mandible 2180 represents an additional, albeit lessdirect pathway, for stimulation of the nerves of the facial region. In apreferred embodiment, a resonant frequency for these bones is utilizedin order to transmit vibrational energy to the nerves within or belowthe bone to achieve a clinical end such as generating tears in the eye,stopping cluster headaches, migraines, seizures, rhinitis, and nasalcongestion.

FIG. 8 depicts the expanded components of one embodiment of a device4100 to stimulate tears. Item 4120 is the housing with an advanced userinterface to allow for gripping the device and then applying to theexternal nasal nerve of a patient. Grip 4125 is a user interface for thedevice which contacts the palm of the user to allow for manipulation ofthe device while the biocompatible tip 4150 is manipulated and appliedto the skin of the patient. The material is biocompatible and firm.Speaker or voice coil 4135 is the heart of the system, allowing for acontinuous spectrum of frequencies, from 50 Hz all the way to kHzfrequency as well as modulation of driving amplitude. Skin interface4150 is stabilized by frame 4110. Frame 4110 also enables finger gripsfor further manipulation of the device. The skin interface 4150 is abiocompatible skin interface which allows for the application of cyclicforce to the external nasal nerve, compressing the nerve against thenasal bone at a frequency of approximately 175 Hz to stimulate the nerveto generate tears. Shaft 4130 underneath the end effector is driven bythe speaker to then drive the end effector element 4150. Interface 4140provides the transduction interface between the speaker 4135 and the endeffector 4150.

FIG. 9 depicts nasal anatomy. The frontal bone 5150 forms the upperboundary of the orbit and maxillary bone 5205 forms the medial boundaryof the orbit. The frontal bone forms the roof of the frontal sinus.Maxillary bone forms the roof of the maxillary sinus 5260. The nares5310 is the communication between the outside and the internal mucosa ofthe nose. The external nasal nerve leaves the nasal cavity through anorifice between the nasal bone 5200 and the lateral processes of theseptal nasal cartilage 5210. It has been discovered that stimulation ofthe external nasal nerve in this region 5215 with force between 1-4 Nusing vibration at 100-300 Hz results in several clinical effectsincluding creation of tears, abrogation of allergic and vasomotorrhinitis, relief from sinusitis, stimulation of meibomian glands,treatment of headaches, and narcolepsy. Stimulation in the region 5100,5290, 5300, 5310, 5230, 5250, 5280, 5300 in some patients have the sameeffect as stimulation of the external nasal nerve. Region 5300 is theregion underneath the skin of the upper lip..i.e. direct mucosa contactabove the gum line of the teeth.

FIG. 10 depicts the cutaneous nervous anatomy 5000 in and around thenasal cavity. Cutaneous, or subcutaneous, generally refers to nervescovered by skin, dead stratified squamous, keratinized epithelial cells.In contrast, mucosa or sub-mucosal, nerves are covered bynon-keratinized mucosal epithelial cells which are generally ciliatedand columnar. Cutaneous nerves are more difficult to reach with certainenergy forms (e.g. electrical stimulation) because the dead stratifiedlayers broadly diffuse the current. However, vibratory stimulation canbe directed to the nerves underlying the skin by transmission ofpressure waves. The external branch of the anterior ethmoidal nerve5020, also referred to as the external nasal nerve, exits at the caudalportion of the nasal bone and supplies the ipsilateral side of the nosewith cutaneous nerve fibers. Infraorbital nerve 5010 supplies cutaneousfibers to the lower eyelid, upper lip, and a portion of the nasalvestibule; the vestibule is the most anterior part of the nose, lined bythe same epithelium as the skin. Its epithelium transitions to therespiratory epithelium of the nasal cavity proper. The infra-trochlearnerve 5035 supplies the skin of the upper eyelids, bridge of the nose,the conjunctiva, lacrimal sac, and the caruncle (small, pink, globularnodule at the inner corner of the eye made of skin covering thesebaceous and sweat glands). The supratrochlear nerve 5030 supplies theskin of the lower forehead, the conjunctiva and the skin of the uppereyelid. It has been discovered through experimentation described hereinthat vibratory stimuli (e.g. 50 Hz to approximately 300 Hz) of thesenerves and nerve endings stimulate the lacrimal nerve to secrete tearsand the meibomian glands to secrete oils and lipid. In theseembodiments, the vibratory stimuli contact the stratified epithelium ofthe skin not the mucosa, and energy is transferred by mechanical waves.In some patients, the mechanical stimuli is effective along thedermatomes of the skin in an around the external nasal nerve. Forexample, in some patients, tear stimulation is possible by applyingvibratory stimulation at approximately 150-300 Hz with the patientinterface as specifically designed herein along the tip of the nose,along the upper lip, along the skin of the lower eyelid, etc. In thesepatients, tolerance to the treatment can in some cases be completelyavoided by applying the treatment to different dermatomes for eachapplication.

In one embodiment, the lacrimal gland is activated by stimulating theinfraorbital nerve, the infra-trochlear nerve, the supratrochlear nerve,the caruncle, or the conjunctiva inside the eyelids. Indeed, theconjunctiva inside the eyelids or on the surface of the eye is mucosaand the upper layers are non-keratinized. Stimulation of these tissuesis optionally performed with vibratory energy including sound,ultrasound, mechanical vibration, electrical sparking, puff of air, puffor water or other liquid, or other mechanically sharp stimulationimpulse. In the mucosal tissues, electrical stimulation is also morepossible because of the lack of stratified epidermis diffusing thecurrent. Therefore, in one embodiment, energy is passed through theconjunctiva of the eye to stimulate tears.

FIG. 11 depicts a handheld embodiment of a device 5500 to applyvibrational energy to the facial region in which there is an underlyingparasympathetic nerve or a circuit which ultimately results instimulation of a parasympathetic nerve. Interface 5510 moves with linearexcursion substantially perpendicular to the housing 5520. Housing 5520is configured to be handheld and self-contained, produced from acomfortable, biocompatible plastic or aluminum material. Interface 5510is fairly rigid with a rounded yet firm tip. The radius of curvature ofthe tip is such that it can firmly push into the junction of the nasalcartilage and nasal bone, vibrate a 100-300 Hz, preferably between 180and 220 Hz or at least between 75 Hz and 300 Hz with maintenance of aconstant speed despite the force being applied by the user to the nerve.

FIG. 12 depicts a detailed view 5550 of the handheld device in FIG. 11 .The basic mechanism of this device is a voice coil 5590 which providesfor a linear driving motion of the tip 5570. Plastic body 5560, 5592surrounds the device. An optical distance sensor 5580 is calibrated todetect movement of the linear vibrating component 5570. Printed circuitboard assembly 5594 comprises an amplifier and battery chargingcircuitry as well as an optional control system so that the tip 5570vibrates at a near constant frequency. Power button 5596 and cover 5592as well as lithium ion batteries 5584 and 5586 complete the unit. Thisunit is self-contained, and the lithium ion batteries are rechargeable.

FIG. 13 depicts the components of a vibratory device 5600 which isconfigured to be held in the palm of the hand of the user with aninterface 5610, 5620 with the tip of a finger of a user. Body surfaceinterface 5650 is configured to be handheld and comfort grip 5694 isconfigured from a biocompatible material. Lithium ion 5692 battery isinserted into the main body housing 5630 (top) 5640 (bottom). Linearvibration motor travels with linear motion and is connected to the bodysurface interface to create linear motion as well. The surface interfaceis applied to the skin with perpendicular application to the skin tostimulate the external nasal nerve and the parasympathetic nervoussystem to open Meibomian glands, create secretions of oils, and producetears from the lacrimal glands, treat migraines, epilepsy, narcolepsy,headaches, open blood brain barrier, equalize pressure, treat rhinitisand sinusitis, and nasal polyps. Tactile switches 5660, 5680 enable userguided feedback to increase or decrease stimulation level, either bysignaling adjustment of the vibration amplitude and/or frequency.Structures 5670 and 5690 house the tactile sensors and transmits thesignals to the use.

FIG. 14 depicts another embodiment of a device 6000 configured to applyvibrational energy to a nerve overlying a parasympathetic nerve of theface. Interface 6020 is a biocompatible skin interface designed totransfer force from the vibratory element to the skin overlying the boneof the patient and to the nerve underlying the bone. A snap element 6010allows for quick placement and removal of the skin interface 6020. Thevibration is generated by eccentric motor 6040 which vibrates thebiocompatible interface with an approximately planar and perpendicularvibratory direction to the long axis of the device 6000. Contactingmotor 6040 are components 6030, 6047 which are intermediate between themotor 6040 and the skin interface 6020. In some embodiments, thesecomponents are flexible or rigid which determines the flexibility orrigidity of the skin interface. In some embodiments, these componentsare even adjustable to create flexible patient interfaces. Switch 6055powers the device on and off. Rechargeable battery 6060 and electricalaccess port 6070 enable power delivery to the device 6000. Additionalelectronics 6045 may include a lockout timer so that a user does notover use the device. A control system to maintain a pre-specified motorand vibration speed is also an optional feature of the circuitry. Theelectronics are housed in shell 6050.

FIG. 15 depicts a device 7000 which can be applied bilaterally to thenose of a patient to stimulate the external nasal nerve simultaneouslyor individually depending on patient preference. A feature of thisdevice is that it has haptic feedback 7825 such that as the patientpresses down on the device switch 7820 and on the nose, the deviceresponds by applying a greater force or displacement to ensure nervestimulation. In other embodiments of FIG. 15 , device 7000 functions asa strip that is applied bilaterally to the nose of a patient such thateach end of the strip contacts the region on the left and right side ofthe nose where the nasal bone meets the anterior lateral nasal cartilagewhere the external nasal nerve is located.

FIG. 16 depicts the underside of the device shown in FIG. 15 . Pressuresensors 7850 sense the force being applied by the user. Material 7855 ispreferably flexible so that the user can squeeze the device and compressthe external nasal nerve and apply increasing vibrational force, thedegree of which is dictated by the force the pressure sensor senses onthe skin. The device is rechargeable via port 7860 which can alsopotentially serve as a data port.

FIG. 17 depicts a schematic of the individual components of the device8000 shown in FIG. 15 . Pressure sensors 8010 enable coupling betweenthe force applied by the user and the speed, torque, and force of theeccentric motors 8020 which create the vibratory effect to stimulate theexternal nasal nerve and parasympathetic pathway. Element 8030 is ahousing for electronics and for the patient to grip while applying thevibration to the external nasal nerve and parasympathetic pathway.Battery 8040 is preferably rechargeable but also may be a replaceablebattery. Cover 8070 seals the electronic circuit board 8050 and chargeport 8060.

FIG. 18 depicts an embodiment 8100 in which the end effector interface8110 moves in a linear direction, actuated by a cam 8150 mechanicallyconnected 8140 to an electric motor 8160. Rotation of the motor linkedto the cam 8150 drives a piston 8120 with an end 8110 which also servesas the biocompatible interface with an edge adapted to activate a nervesuch as the external nasal nerve. The piston 8120 and biocompatibleinterface 8110 move at an optimal frequency between 100 and 300 Hz orbetween 50 Hz and 400 Hz. The cam 8150 can be offset from the centralaxis 8140 to determine the excursion of the piston (e.g. 1 mm) andinterface which then applies force to the skin of the patient and thento the nerve to be stimulated. In some embodiments, a governor isincluded to ensure that the frequency that is set by the user orpre-determined before delivery to the user is the actual frequency ofthe piston excursion. For example, in one embodiment, a photodiode orother detector is utilized to detect motion of the electric motor,linkages, or the piston; if the revolutions per minute (RPM) are not aspre-specified, additional current is added or subtracted from the motor.Electronic circuitry is also included which enables the device to recordthe time of treatment, time between treatments as well as a lock outtime in between treatments (e.g. to ensure that the device is notoverused or underused). Such data is stored in memory and isdownloadable offline to a PC as a record of usage and compliance withthe device in real world practice or in a clinical trial setting. Thecircuit further controls the voltage to ensure a constant power to themotor and constant rotation which can be pre-set or varied by the user.

FIGS. 19A-19B depict a carpal ligament 9002 and median nerve 9004 of ahand 9000 and wrist 9010 of an individual. Carpal Tunnel Syndrome (CTS)is a medical condition due to compression of the median nerve 9004 as ittravels through the wrist 9010 at the carpal tunnel. The main symptomsare pain, numbness, and tingling, in the thumb, index finger, middlefinger, and the thumb side of the ring fingers. In some embodiments, thedevices and methods described herein may be used to stimulate ordecompress the median nerve 9004 as it travels through the wrist 9010,for example by providing external ultrasound and/or mechanical vibrationto a region adjacent to or on top of the median nerve 9004.

FIG. 20 depicts various mechanisms through which a pore on a skinsurface 9020 becomes plugged. A skin surface 9020 includes numerouspores 9006, and these pores 9006 can become plugged for any variety ofreasons, for example overactive sebaceous glands 9008, bacteria 9012,deadline skin cells 9014, and inflammation 9016, among other mechanisms.In some embodiments, the devices and methods described herein may beused to disrupt the causative agent of the plugged pore, for example byproviding external ultrasound and/or mechanical vibration to a regionadjacent to or on top of the pore.

Turning to FIG. 21 . FIG. 21 depicts another embodiment of a device 9030which generates substantially one-dimensional vibratory or oscillatorymotion to be applied to the skin or eye structure of a patient, asdescribed elsewhere herein. Device 9030 uses effector tip 9018 toprovide mechanical vibration to a skin surface or eye structure tostimulate a nerve (e.g., external nasal nerve, median nerve, etc.),inhibit a nerve, treat a skin condition, induce tear production, clearcongestion, treat sinusitis, or any other condition known in the artand/or described elsewhere herein. For example, as shown in FIG. 22 ,oscillation of effector tip 9018 of device 9030 is applied to thejunction of the nasal bone and the anterior lateral nasal cartilagewhere the external nasal nerve 9022 is located. In some embodiments,effector tip 9018 of device 9030 is applied to the external nasal nerveto treat, for example, congestion or sinusitis.

In some embodiments, device 9030 is incorporated into a phone case, forexample insertable into a pocket of a case or attachable to a case.

In some embodiments, device 9030 is associated with an applicationconfigured to run on another user device, for example a mobile device,smart watch, or computer, to track, monitor, and/or modulate device 9030performance.

In some embodiments, as shown in FIGS. 21-22 , device 9030 includeshousing 9024. Housing 9024 functions to at least partially encapsulateor house one or more components of device 9030. For example, effectortip 9018 is partially housed within housing 9024 but also protrudes orextends from housing 9024 via aperture 9028 defined by one or moresidewalls of housing 9024. Alternatively, in some embodiments, device9030 does not include a housing, but rather includes a plate or surface(e.g., flat or irregular) to which one or more components of device 9030are coupled, attached, adhered, or otherwise fastened. Further, thehousing 9024 of some embodiments includes or is formed of two or morehalves or pieces such that the two or more halves or pieces are coupled,attached, bonded, adhered, or otherwise fastened together. The two ormore halves may be reversibly coupled or irreversibly coupled. In otherembodiments, housing 9024 is formed of a monolithic piece or structure(i.e., consisting of one piece). Housing 9024 includes or is formed of aplastic, for example polyamide, polycarbonate, polyester, polyethylene,polypropylene, polystyrene, polyurethane, polyvinyl chloride,polyvinylidene chloride, acrylonitrile butadiene styrene, or any otherplastic or material known in the art. In some embodiments, as shown inFIG. 21 , housing 9024 includes a beveled or contoured region 9026 toaccommodate effector tip 9018. Contoured region 9026 may be sized andshaped similar to effector tip 9018, for example substantially circularin shape or partially circular in shape (e.g., semi-circular).

In some embodiments, device 9030 further includes retractor 9068, asshown in FIG. 26 . Retractor 9068 functions to retract an eye lid oranother body portion or structure of a user so that ultrasound and/orvibration can be applied to a surface of the lid, eye, or an eyestructure in or around the eye of the user. A first end 9074 ofretractor 9068 may be movably coupled to housing 9024, for example via ahinge, joint, or pivot point. In other embodiments, retractor 9068 iscoupled to a plate or other surface to which components of device 9030are coupled. A second end 9076 of retractor may have a curved shapedwith an atraumatic surface for contacting and retracting an eye lid orother body portion or structure of the user.

Turning now to FIGS. 23-24 . FIG. 23 is a schematic representation ofone embodiment of device 9030 of FIG. 21 , and FIG. 24 depicts across-sectional view of one embodiment of the device of FIG. 21 . FIGS.23-24 shows various components 9040 of device 9030. For example, one ormore components of device 9030 may include: memory or storage medium9032, a power switch 9034, a charge indicator 9036, a controller 9038, apower source charging port 9042, a battery voltage detector 9044, apower source 9046, a direct current (DC)-to-DC converter 9048, a driver9052, a motor 9054, I/O device 9056 (e.g., non-volatile mediumreader/writer), circuit board 9072, effector tip 9018, and cantileverbeam 9062. Each component will be described in detail with reference toFIGS. 23-24 .

One or more components 9040 described herein are mounted to circuitboard 9072, for example a printed circuit board, and electricallyinterconnected via the circuit board 9072, as shown in FIG. 24 .

In some embodiments, as shown in FIGS. 23-24 , device 9030 includesstorage medium 9032 (e.g., SD card). Storage medium 9032 includes one ormore of RAM, ROM, flash memory, EEPROM, a hard disk drive, a solid-statedrive, or any other suitable device. In some embodiments, data is storedin non-volatile memory on storage medium 9032; in other embodiments,data is stored in volatile memory on storage medium 9032. Storage medium9032 stores data, for example use data, battery voltage data, DC-to-DCconverter data, etc. In some embodiments, storage medium 9032 isremovable from device 9030 to extract and/or analyze use data; in otherembodiments, storage medium 9032 is not accessible but rather data isremoved from the storage medium through a port (e.g., IEEE 1934,thunderbolt, lightning, etc.) on the device 9030. Data is written to andfrom storage medium 9032 via I/O device 9056. For example, the I/Odevice 9056 of some embodiments may be an SD reader/writer.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includespower switch 9034 accessible by a user on an exterior of housing 9024 ofdevice 9030. Power switch 9034 activates or deactivates device 9030.Power switch 9034 may be a button, toggle switch, or any other switchknown in the art. When power switch 9034 is selected by a user toactivate device 9030, driver 9052 (e.g., MOSFET driver) is activated todrive motor 9054 (e.g., eccentric motor) which oscillates cantileverbeam 9062 and effector tip 9018, as described in further detailelsewhere herein.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includes apower source 9046. In some embodiments, power source 9046 is arechargeable battery (e.g., Lithium ion battery); in other embodiments,power source 9046 is a disposable battery. In some such embodiments, forexample, the device 9030 may be disposed of once the power source 9046is depleted. Power source 9046 is configured to hold a charge for anextended period of time, for example greater than 1 week, 2 weeks, 3weeks, or any range or subrange therebetween. During extended periods ofnon-use, power source 9046 enters into a low power mode, such that thecurrent drops to the nanoamperes (nA) range, for example substantially200 nA. In some embodiments, device 9030 enters a “deep sleep” modeduring extended periods of non-use. Such modes are interrupted byactivation or toggling of the power switch 9034. In some embodiments,power source 9046 is configured to maintain a small percentage ofcharge, for example 5%, 10%, 15%, or 20%, or to not drain power below acertain percentage or threshold so that data may be removed from storagemedium 9032 and/or charge indicator 9036 may be illuminated to indicatean energy deficient, power required state of device 9030. In suchstates, the device 9030 does not function to provide a treatment sessionto protect a user from an incomplete or inefficient treatment session,for example due to insufficient voltage supplied to the motor.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includes apower source charger 9042. Power source charger 9042 is a port forreceiving an adapter therein to charge or supply power to power source9046. In some embodiments, power source charger 9042 is a USB port; inother embodiments, power source charge 9042 is an IEEE 1934,thunderbolt, lightning, etc. port. Alternatively, in some variations,power source charger 9046 is an inductive charging surface or a solarpanel.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includes acharge indicator 9036 visible on an exterior of housing 9024 of device9030. Charge indicator 9036 indicates whether device 9030 has sufficientcharge to operate device 9030 or whether charging is required before asubsequent treatment cycle. In some embodiments, charge indicator 9036is a light-emitting diode (LED) or a series of LEDs; in otherembodiments, charge indicator 9036 is another type of light-emittingdevice (e.g., OLED) or color indicator. For example, charge indicator9036 may fluoresce green or emit a green colored light when power source9046 is fully charged and yellow, orange, or red when power source 9046requires power input or recharging. In some embodiments, chargeindicator 9036 includes a series of indicators such that in a fullycharged state, all indicators are illuminated and/or a pre-determinedcolor, and as charge is used, fewer indicators are illuminated and/orthe indicators change color.

In some embodiments, as shown in FIGS. 23-24 , the controller 9038 andI/O device 9056 are coupled, via one or more buses, to the storagemedium 9032 in order to read information from, and write information to,the storage medium 9032. For example, controller 9038 receivesinformation from one or more of: charge indicator 9036, driver 9052,DC-to-DC converter 9048, power source 9046, battery voltage detector9044, power source charger 9042, power switch 9034, storage medium 9032,I/O device 9056, and/or any other component. In some embodiments,controller 9038 receives a treatment start time, a power source voltagewhen motor 9054 is in an off state; a power source voltage when motor9054 is in an on state; a DC-to-DC converter voltage; a treatment toptime; a number of treatment sessions; a treatment duration (e.g.,instant, previous, average, median, etc.); or any other relevantinformation for any one or more of components 9040.

In some variations, device 9030 includes a search mode. For example, asearch mode may include one or more presets, each representing adifferent frequency of effector tip oscillation. Once search mode isactivated, for example by a user depressing the effector tip for apre-determined period of time or selecting a user input element, device9030 may cycle through each of the pre-sets to allow the user todetermine which pre-set is the most effective for achieving the desiredtherapeutic response. In some embodiments, each pre-set has a slightlyhigher or lower frequency than the preceding pre-set. Alternatively oradditionally, each pre-set has a slightly greater or lesser force thanthe preceding pre-set. Once the user has identified an ideal pre-set toachieve the desired therapeutic effect, the user selects the desiredpre-set, for example by double pressing the effector tip when the device9030 reaches the pre-set during the cycle, by selecting the pre-setusing a user input element (e.g., button, switch, toggle, etc.), or byanother method known in the art.

In some embodiments, device 9030 includes one or more intensity modes,for example ranging from soft to intermediate to intense. The user mayselect an intensity mode using a user input element (e.g., button,toggle, etc.) or, in some embodiments, device 9030 is preconfigured withan intensity based on the desired clinical application.

In some embodiments, device 9030 includes a pressure sensitive switch ora power switch 9034 of device 9030 is a pressure sensitive switch. Forexample, the pressure sensitive switch senses a continuum of force whenpressed lightly to more firmly; this output can then be used to modulatethe device’s vibratory frequency, amplitude, or both. In someembodiments, multiple switch presses vary an output frequency of device9030. In some embodiments, multiple switch presses vary an outputamplitude of device 9030.

In some embodiments, device 9030 is disposable. For example, a number oftreatments (e.g., 100, 200, 300, 400, 500, less than 500, more than 500treatments, or any range or subrange there between) performed by device9030 may be read by controller 9038 of the device 9030 and written tostorage medium 9032, for example via I/O device 9056, such that thedevice becomes inactive or is in a permanent off state once a thresholdnumber of treatments has been reached. In other embodiments, device 9030is reusable. For example, a power source 9046 of device 9030 may berechargeable and/or replaceable.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includes abattery voltage detector 9044. Battery voltage detector 9044 determineswhether voltage coming from power source 9046 or power source charger9042 is in a safe range (i.e., to prevent any current extremes), forexample to protect a skin surface or eye of the user from effector tipfrequencies or forces that may cause abrasions or ineffective treatment.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includes avoltage converter 9048, for example a DC-to-DC converter (e.g.,buck-boost converter). Voltage converter 9048 produces an output voltagemagnitude that is either greater than or less than the input voltagemagnitude. In some embodiments, revolutions per minute (RPM) of themotor 9054 and ultimately a frequency of effector tip 9018 oscillationis increased or decreased when a voltage supplied to the motor 9054 isincreased or decreased, respectively. In such embodiments, amanufacturer, healthcare provider of the user, or user of device 9030can set or control an intensity of effector tip 9018 oscillation bycontrolling the voltage output by the voltage converter 9048.

In some embodiments, as shown in FIGS. 23-24 , device 9030 includesmotor 9054. Motor 9054 functions to oscillate effector tip 9018 via, forexample, beam 9062, as will be described in further detail elsewhereherein. In some embodiments, motor 9054 is an eccentric rotating mass(ERM) motor using an unbalanced weight or mass 9066 but may also be anyother type of motor known in the art, for example a linear resonantactuator. The ERM is configured to cause the beam 9062 to vibrate(oscillate) while the beam 9062 is carrying the motor 9054. Inparticular, because the beam 9062 is carrying the motor 9054, rotationof the mass 9066 by the motor 9054 will cause the beam 9062 togetherwith the motor 9054 to oscillate in a desired direction, for exampleperpendicular to a surface 9058 of tissue. In some embodiments, themotor 9054 may be configured to rotate the ERM at a certain frequencythat maximizes a vibrational amplitude of the effector tip 9018. Inother embodiments, the motor 9054 may be configured to rotate the ERM atother frequencies, which do not necessarily maximize a vibrationalamplitude of the effector tip 9018. Also, in some embodiments, the motor9054 is configured to rotate the mass 9066 at a frequency thatcorresponds with the natural frequency of the beam 9062 (with the massof the motor 9054). For example, the motor 9054 may rotate the mass 9066at a frequency that is equal to, or near the natural frequency fn of thebeam 9062 (with the mass of the motor 9054) - e.g., fn ± 0.1fn. In otherembodiments, the motor 9054 may be configured to rotate the mass 9066 atother frequencies that may not correspond with the natural frequency ofthe beam 9062 (with the mass of the motor 9054). In some embodiments,device 9030 includes a modular motor that can be changed or altered by auser or prescribing health professional to better match a frequency oramplitude of device output to a user’s needs.

In some embodiments, a majority of a length of the beam 9062 may have across section shaped with a certain orientation to ensure that the beam9062 will undergoing bending action in a desired direction in responseto the turning of the eccentric mass 9066 by the motor 9054. Forexample, the beam 9062 may have a rectangular cross section having along side and a short side. The cross section may be oriented so thatthe long side of the rectangular cross section is perpendicular to adesired bending direction 9067 of the beam 9062 (e.g., is parallel tothe Z-axis), and so that the short side is parallel to the desiredbending direction (e.g., parallel to the Y-axis). This configurationorientates the beam 9062 so that its weaker bending stiffness isassociated with bending action within the X-Y plane, and its strongerbending stiffness is associated with bending action within the X-Zplane. As a result, the beam 9062 is more easily bend within the X-Yplane than within the X-Z plane. In other embodiments, the beam 9062 mayhave other cross sectional shapes, such as an elliptical shape, aT-shape, or any of other shapes. Also, in some embodiments, a crosssectional moment of inertia of a cross section of the beam 9062 aboutthe Z-axis is less than a cross sectional moment of inertia of the crosssection of the beam 9062 about the Y-axis. This feature also provides anorientation of the beam 9062 so that its weaker bending stiffness isassociated with bending action within the X-Y plane, and its strongerbending stiffness is associated with bending action within the X-Zplane. As a result the beam 9062 is more easily bend within the X-Yplane than within the X-Z plane.

Also, in some embodiments, electrical wires from the motor 9054 may beattached to the beam 9062 to avoid any relative movement between thebeam 9062 and the electrical wires. For example, the beam 9062 may haveone or more openings or frames for allowing the electrical wires toextend therethrough, thereby allowing the beam 9062 to carry theelectrical wires, and allowing the beam 9062 and the electrical wires tomove (vibrate) together. In some embodiments, a majority of a length ofthe electrical wires, or portion(s) of the electrical wires, may becoupled to an external surface of the beam 9062. In other embodiments, amajority of a length of the electrical wires, or portion(s) of theelectrical wires, may be coupled internally within the beam 9062. Inother embodiments, the electrical wires from the motor 9054 may not beattached to the beam 9062.

In the illustrated embodiments, the motor 9054 is attached to the beam9062 so that the motor 9054 and the beam 9062 can move (e.g., vibrate)together in response to the motor 9054 turning an eccentric rotatingmass 9066 attached to a shaft of the motor 9054. This feature isadvantageous because it allows the device 9030 to operate more quietly.In particular, because the motor 9054 is configured to cause the beam9062 to vibrate together with the motor 9054 without using anymechanical linkage that moves and touches against the beam 9062, thereis no noise generated from any moving part touching the beam 9062. Also,for this same reason, the chance of the beam 9062 having wear and tearand having mechanical failure is substantially reduced, and the device9030 has a relatively longer lifetime (at least compared to theembodiment of FIG. 18 that uses a reciprocal motor 9054, or to atechnique that involves the motor moving the beam via mechanical linkagethat moves and touches the beam).

In other embodiments, instead of having the motor 9054 immovablyattached to the beam 9062, the device 9030 may include a motor that isimmovably attached to the housing or to a frame within the housing. Insuch cases, the motor 9054 is configured to move the beam 9062 in anoscillatory manner via mechanical linkage, and the beam 9062 isconfigured to move relative to the motor 9054.

In some embodiments, device 9030 may include two or more motors acting(e.g., causing vibration) on a beam. The two or motors may be arrangedorthogonally or at angles with respect to one another to providevibratory control in multiple planes of motion.

In some embodiments, device 9030 includes two or more motors aligned inthe same plane but spinning in opposite directions amplifying motion ina primary direction but canceling motion in a secondary lateraldirection. In some embodiments, device 9030 includes two or motorsacting on a beam to provide increased vibratory amplitude in a primarydirection of motion.

In some embodiments, device 9030 includes a transmitter or transceiver,for example to communicate data to nearby devices including cell phones,computers, and smart watches.

In some embodiments, device 9030 is equipped with a biometric reader,for example a fingerprint or eye scanner or facial recognition software.Biometric reader may be configured to limit device 9030 use to one ormore users.

In some embodiments, device 9030 includes electronics, software, and/orone or more parameters that limit device 9030 use to a prescribed numberof treatments.

In some embodiments, device 9030 includes a display configured todisplay use data, a treatment duration, a treatment frequency, atreatment history, a prescribed treatment regimen, a frequency ofvibration, an amplitude of vibration, etc. or to prompt a user to applya treatment using device 9030.

In some embodiments, device 9030 includes a visual, auditory, and/orhaptic modality for alerting a user that it is time to use device 9030for a treatment session and/or that the prescribed duration of use hasbeen achieved.

Turning now to effector tip 9018 and beam 9062. Effector tip 9018functions as the treatment surface, for example for contacting a skinsurface or an eye structure of a user. In some embodiments, effector tip9018 includes or is formed of a plastic, for example acrylonitrilebutadiene styrene, but may also be any other plastic or material knownin the art. Effector tip 9018 is shaped and configured to have smoothcontours to limit unintended abrasions during use but to eliciteffective treatment. In some embodiments, a durometer of the effectortip 9018 is between 20A to 80A, 30A to 70A, 40A to 60A, 40A to 50A, 50Ato 60A, 45A to 55A, or any range or subrange therebetween. The durometerof effector tip 9018 is configured to induce effective treatment whilelimiting unintended effects, such as abrasions.

In some embodiments, effector tip 9018 is replaceable and/or can beequipped with elastomers of varying stiffness to better meet the comfortneeds of each user.

In some embodiments, effector tip 9018 includes a conductive heatingelement, for example a resistive coil to heat tissue while in operation.In other embodiments, effector tip 9018 includes a radiative heatingelement, for example an infrared light to heat tissue while inoperation. The radiative heating element of some embodiments radiateselectromagnetic energy between 400-1000 nm wavelength at effector tip9018.

Effector tip 9018 is coupled to beam 9062 (e.g., two components coupledtogether or as a monolithic component) and oscillates as result of motor9054 movement via contact with beam 9062 and effector tip 9018. Theoscillation is dictated by a combination of the motor rotation and theweight and geometry of beam 9062 and the reactions at coupling element9064. A stiff coupling element 9064 will result in a lower frequencywhereas a loose coupling element 9064 will result in a higher frequencybut also less force per revolution on a surface of the patient. Theeffector tip 9018 oscillates with a substantially fixed amplitude inair. For example, the substantially fixed amplitude is between about 0.1and 2 mm, 0.2 mm and 1.8 mm, 0.25 mm and 2 mm, 0.25 mm and 1.5 mm, orany range or subrange therebetween. In some embodiments, the fixedamplitude is substantially 1 mm, greater than 0.1 mm, greater than 0.2mm, less than 2 mm, less than 1.75 mm, less than 1.5 mm, or any value,range, or subrange therebetween.

The effector tip 9018 oscillates with a force, such force being relatedto a natural frequency of beam 9062 and a frequency of oscillation ofmotor 9054, as described in more detail elsewhere herein. In someembodiments, the effector tip oscillates with a force of substantially0.5 N to 5 N, 1 N to 3 N, less than 5 N, less than 4 N, less than 3 N,greater than 0.5 N, greater than 0.75 N, greater than 1 N, or any value,range, or subrange therebetween.

The effector tip 9018 oscillates with a frequency, such frequency beingrelated to a natural frequency of beam 9062 and a frequency ofoscillation of motor 9054, as described in more detail elsewhere herein.In some embodiments, a frequency of oscillation of the effector tip 9018is substantially 5 Hz to 500 Hz, 25 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hzto 250 Hz, greater than 25 Hz, greater than 50 Hz, less than 500 Hz,less than 300 Hz, less than 250 Hz, or any value, range, or subrangetherebetween.

In some embodiments, a frequency, force, and/or amplitude of effectortip 9018 oscillation is dampened by an amount of force a user applies tothe device 9030 against a surface 9058; in other embodiments, afrequency or force of effector tip 9018 oscillation is maintainedregardless of an amount of force a user applies to the effector tip 9018against a surface 9058, for example as shown in FIG. 18 . For example, auser of device 9030 controls an intensity of a treatment session bycontrolling an output force and/or frequency of oscillation of effectortip 9018. The beam 9062 bends when a force is applied to the effectortip 9018, such that bending beam 9062 slows motor 9054 and reduceseffector tip 9018 oscillation. Such force and/or frequency of effectortip 9018 is controlled by the user applying force to the effector tip9018 during a treatment session. For example, a frequency of oscillationof the effector tip 9018 is dampable when a force of substantially 0.5N, 0.6 N, 0.7 N, 0.8 N, 0.9 N, 1 N, 1.1 N, 1.2 N, 1.3 N, 1.4 N, 1.5N,greater than 0.75 N, greater than 0.8 N, greater than 0.9 N, less than1.2 N, less than 1.1 N, or any force value in between is applied toeffector tip 9018. Correspondingly, the amplitude of oscillation ofeffector tip 9018 is dampable when a force of substantially 0.5 N, 1 N,1.1 N, 1.2 N, 1.3 N, 1.4 N, 1.5 N, 1.6 N, 1.7 N, 1.8 N, 1.9 N, 2 N, 2.1N, 2.2 N, 2.3 N, 2.4 N, 2.5 N, greater than 1.5 N, less than 2.5 N, orany force value therebetween is applied to effector tip 9018. Thedampable nature of effector tip 9018 is critical for the atraumatic useof device 9030. In embodiments where effector tip 9018 is not dampable,a user applying a greater force than is required for effective treatmentmay result in abrasions on the skin surface or eye structure because afrequency or amplitude of oscillation of effector tip 9018 would notadjust in response to the applied force.

In some embodiments, device 9030 includes a motion sensor, for examplean accelerometer, gyroscope, inertial sensor, etc. to measure vibratoryoutput that may be fed into the device’s control loop.

In some embodiments, as shown in FIG. 24 , device 9030 includes beam9062 coupled to effector tip 9018. Beam 9062 is coupled to device 9030via a coupling element 9064 (e.g., a bracket, joint, fastener, pivotpoint, hinge, etc.). Coupling element 9064 couples beam 9062 to housing9024 or to a plate or surface to which the components are coupled. Beam9062 functions to maintain oscillation of effector tip 9018 insubstantially one dimension, for example perpendicular to a surface. Insome embodiments, there is additional motion parallel to the surface.The beam 9062 constrains oscillation of the motor into substantially onedirection (i.e., perpendicular to surface D_(perp) in a direction y), asshown in FIG. 25 , but, in some embodiments, there is also movement in aplane parallel to the surface D_(par) in a direction z. In someembodiments, a ratio of movement parallel D_(par) to the surface versusperpendicular D_(perp) to the surface is 1:2, 1:4, 1:8, 1:12, 1:16, orany ratio therebetween. For example, for every one movement parallel tothe surface there are four movements perpendicular to the surface. Insome embodiments, movement in one direction parallel to the surface isless than 1 mm; in other embodiments, movement in one direction parallelto the surface is substantially 1 mm, 1-1.5 mm, 1.5-2 mm, 2-2.5 mm,2.5-3 mm, less than 5 mm, or any value, range, or subrange therebetween.

In some embodiments, device 9030 includes a modular beam that can bechanged or altered by a user or prescribing health professional tobetter match a frequency or amplitude of device output to a user’sneeds.

In some embodiments, device 9030 includes two or more beams. In someembodiments, the two or more beams are oriented to simultaneouslystimulate tear production in left and right eye, for example bystimulating the external nasal nerve on both the right and left side ofa nose of a user.

Further, the geometry of the beam 9062 results in beam 9062 having anatural frequency at substantially 200 Hz (e.g., 200 Hz ± 20 Hz); theoscillation frequency of the motor 9054 is set to substantially thenatural frequency of beam 9062 or the natural frequency of beam 9062plus coupling element 9064, so that the beam 9062 and the motor 9054work synergistically. In some embodiments, the dimensions of beam 9062are 4 mm wide, 3 mm deep and 50 mm in length. In other embodiments, thedimensions of beam 9062 range from 2-8 mm wide, 1-6 mm deep, and 25-75mm in length, or any range or subrange therebetween. For example, sincebeam 9062 is substantially constrained to rotation in a plane, it issufficient to consider its moment of inertia about an axis perpendicularto the plane. The following equation (1) may be used:

$\begin{matrix}{\text{I} = {\text{bd}^{3}/12}} & \text{­­­(1)}\end{matrix}$

-   where I is the moment of inertia (angular mass or rotational    inertia),-   b is the width of beam 9062, and-   d is the depth of beam 9062.

A natural frequency of beam 9062 is calculated, for example, accordingto the equations (a) through (d) in FIG. 31 , in which:

-   m is a mass per unit length of the beam 9062,-   L is the distance from the fixed end of beam 9062,-   E is the modulus of rigidity of the material of beam 9062,-   I is the moment of inertia (calculated in (1)) of beam 9062,-   ω is the natural frequency (ω₁, ω₂, w₃; first, second, third natural    frequency, respectively) of beam 9062,-   f(x) is displacement in y direction at distance x from fixed end of    beam 9062, and-   1.875, 4.694, and 7.855 are constants α_(n).

The calculated or determined natural frequency of beam 9062 or beam 9062plus coupling element 9064 can then be used to tune a frequency ofoscillation of motor 9054. As will be described in further detail inconnection with FIGS. 27-28B, even small changes or adjustments in thedimensions or geometry of beam 9062 can have profound effects on thenatural frequency of beam 9062 and thus the frequency to which motor9054 is tuned.

In some embodiments, oscillation frequency based on beam dimensions issimulated to account for a shape of beam 9062 and a motor 9054 mountedto the end of beam 9062 to model the complex geometries of beam 9062 andheterogenous material properties of beam 9062.

Turning now to FIG. 27 . FIG. 27 depicts a test fixture 9070 for testinga device, for example device 9030 or any device described elsewhereherein, to determine a force output of device 9030. Text fixture 9070includes a frame 9078 including holder 9092, two or more members 9082,sensor 9084, and plate 9086. The two or more members 9082 are coupled toplate 9086 at a first end 9088 a and to frame 9078 at a second end 9088b. Members 9082 suspend plate 9086 in frame 9078, as shown in FIG. 27 .In some embodiments, members 9082 are elastic; in other embodiments,members 9082 are more rigid or inflexible. The material of members 9082is dictated by a type of test to be conducted with test fixture 9070.Device 9030, or any device described elsewhere herein, rests in holder9092 of frame 9078 during testing. Plate 9086 is a contact surface foreffector tip 9018 during testing and includes one or sensors 9084. Insome embodiments, sensor 9084 is a motion sensor (e.g., accelerometer,gyroscope, etc.); in other embodiments, sensor 9084 is a force sensor,pressure sensor, camera, temperature sensor, touch sensor, proximitysensor, optical sensor, colorimeter, tactile sensor, or any other sensorknown in the art.

In the example shown in FIGS. 28A-28B, effector tip 9018 of device 9030contacts sensor 9084, an accelerometer, on plate 9086 of text fixture9070. The sensor 9084 measures the dynamic acceleration of effector tip9018 as a voltage, which can then be used to calculate or estimate aforce exerted by effector tip 9018. Since plate 9086 and sensor 9084have a known mass, an output force of effector tip 9018 can be estimatedusing the following equation (2):

$\begin{matrix}{\text{F} = \text{m * a}} & \text{­­­(2)}\end{matrix}$

-   where F is the output force of effector tip 9018,-   m is a combined mass of plate 9086 and sensor 9084, and-   a is the acceleration as measured by sensor 9084.

The dynamic acceleration, shown as amplitude vs. frequency, of exemplarybeam 9062 of device 9030 is shown in FIG. 28A and a beam with a thickercross-section is shown in FIG. 28B. As shown in FIG. 28A, the geometryof the beam was selected to have a desired output frequency (Hz) andamplitude (mm), for example substantially 270 Hz and 148 mm, to producea desired therapeutic effect elicited by effector tip 9018 of device9030. In contrast, changing the geometry of the beam, even by 1 mm,drastically changes a frequency of effector tip oscillation. Forexample, as shown in FIG. 28B, increasing a thickness of the beamcross-section by 1 mm drastically reduced a frequency of effector tiposcillation (from substantially 230 Hz to substantially 78 Hz).

Using test fixture 9070 for commercially available devices reveals thatthese devices do not result in the same motion, frequency, amplitude,and/or force as device 9030. For example, commercially available backmassage devices, Sonicare® devices, or devices using reciprocal motorsto elicit beam movement do not output the correct motion or skininterface, nor the correct frequency, force, and/or amplitude to elicita beneficial, atraumatic, and/or quiet therapeutic effect. As aconsequence, these other commercially available devices do not deliverthe therapeutic effect of inducing tears or providing relief fromcongestion, for example rhinosinusitis.

TABLE 1 Function and Efficacy of Commercially Available Devices DeviceFrequency (Hz) Force Output Clinical Efficacy Shape of interfaceiTEARgen1 180 180 Minimal 90 degree angle iTEARgen2 270 180 Yes 90degree angle Sonicare 263 85 Minimal Smooth Dr. Johnson 130 141 NoSmooth/ Rounded Wahl Deep Tissue 90 95 No Smooth/ Rounded Evolved 127180 No Smooth/ Rounded First Time 141 80 No Smooth/ Rounded

Table 1 above relates force and frequency measured by the test fixture9070 to clinical efficacy in a selection of commercially availabledevices. The tips of the devices and the shape of the tips were chosenfrom a larger group of commercially available devices due to theirpotential to activate nerves related to lacrimation and nasaldecongestion. The clinical efficacy is an increase in tearing from thelacrimal gland and a decrease in nasal congestion. As shown in Table 1,very few devices that were tested were clinically effective. This lackof clinical efficacy is likely due to the shape of the interface and thecombined force and frequency output of the effector tip.

As shown in Table 1, iTEARgen1 was modestly effective in stimulatingtear production and iTEARgen2 was more effective than iTEARgen1,producing the desired clinical effect in over 99% of patients. Thefrequency, force, and movement of iTEARgen2 makes it a significantlyimproved device compared to iTEARgen1. However, both are significantlybetter than commercially available massager devices which serve otherpurposes. The other devices (i.e., Sonicare, Dr. Johnson, Walh DeepTissue, Evolved, First Time) in Table 1 are commercial devices sold asmassagers for various body regions.

FIGS. 29A-29B depict various views of an effector tip, similar to theeffector tip of iTEARgen1 and gen2, which was successful in clinicalefficacy. As shown in FIGS. 29A-29B, the effector tip has sharp, 90degree edges. In contrast, FIGS. 30A-30B depict various views of an endeffector, which was clinically ineffective. As shown in FIGS. 30A-30B,the effector tip has rounded or smooth surfaces. As described hereinwith respect to device 9030 of FIGS. 21-26 and in direct contrast to theresults presented in Table 1, the effector tip 9018 of device 9030achieves clinical efficacy while also having a narrow smooth surfacewith defined edges on the effector tip 9018. Such efficacy is due inpart to the shape and composition of the effector tip 9018 but also theunique mechanisms (e.g., eccentric motor, beam, etc.) of device 9030that are used to induce effector tip 9018 vibration/oscillation.

There are additional differences between the commercially availabledevices which do not have an indication for dry eye and which do notwork for dry eye. For example, effector tips on the commerciallyavailable devices do not move independently from the housing on thedevice. Such an arrangement is necessarily inefficient because theentire housing vibrates as opposed to all the force being delivered tothe interface by the effector tip. In other words, the pressure is lowerover the larger surface of the device which is less effective thanhigher pressure over the smaller surface area of the effector tip. Inthe currently described device 9030, the effector tip 9018 movesindependently from the housing 9024, oscillating in and out of thehousing or substantially outside the housing to apply its therapeuticbenefit and maximizing the force applied to the patient’s external nasalnerve. The motor 9054 is inside the housing 9024 and communicates withthe effector tip 9018 through a physical connection which might be amechanical linkage, an electromagnetic coupling, or a direct connectionto the effector tip 9018. The housing 9024 is merely required so thatthe operator can hold the device 9030.

In one or more embodiments described herein, the device may be designedwith low cost and form factor, which encourages compliance andfacilitates its utilization.

As used in the description and claims, the singular form “a”, “an” and“the” include both singular and plural references unless the contextclearly dictates otherwise. For example, the term “effector” mayinclude, and is contemplated to include, a plurality of effector tips.At times, the claims and disclosure may include terms such as “aplurality,” “one or more,” or “at least one;” however, the absence ofsuch terms is not intended to mean, and should not be interpreted tomean, that a plurality is not conceived.

The term “about” or “approximately,” when used before a numericaldesignation or range (e.g., to define a length or pressure), indicatesapproximations which may vary by ( + ) or ( - ) 10%, 5%, 1% 0.1%, or 0%.All numerical ranges provided herein are inclusive of the stated startand end numbers. The term “substantially” indicates mostly (i.e.,greater than 50%) or essentially all of a device, substance,composition, a metric, a value, a parameter, etc.

As used herein, the term “comprising” or “comprises” is intended to meanthat the devices, systems, and methods include the recited elements, andmay additionally include any other elements. “Consisting essentially of”shall mean that the devices, systems, and methods include the recitedelements and exclude other elements of essential significance to thecombination for the stated purpose. Thus, a system or method consistingessentially of the elements as defined herein would not exclude othermaterials, features, or steps that do not materially affect the basicand novel characteristic(s) of the claimed disclosure. “Consisting of”shall mean that the devices, systems, and methods include the recitedelements and exclude anything more than a trivial or inconsequentialelement or step. Embodiments defined by each of these transitional termsare within the scope of this disclosure.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. Other embodiments may be utilized andderived therefrom, such that structural and logical substitutions andchanges may be made without departing from the scope of this disclosure.Thus, although specific embodiments have been illustrated and describedherein, any arrangement calculated to achieve the same purpose may besubstituted for the specific embodiments shown. This disclosure isintended to cover any and all adaptations or variations of variousembodiments. Combinations of the above embodiments, and otherembodiments not specifically described herein, will be apparent to thoseof skill in the art upon reviewing the above description.

Although particular embodiments have been shown and described, it willbe understood that it is not intended to limit the claimed inventions tothe preferred embodiments, and it will be obvious to those skilled inthe art that various changes and modifications may be made withoutdepartment from the spirit and scope of the claimed inventions. Thespecification and drawings are, accordingly, to be regarded in anillustrative rather than restrictive sense. The claimed inventions areintended to cover alternatives, modifications, and equivalents.

What is claimed is:
 1. A method of inducing tear production in an individual, comprising: receiving a signal generated based on a manipulation of a control at a handheld device; and activating a motor after receiving the signal to oscillate a member at an oscillation frequency, the member having a portion for placement outside the individual; wherein the oscillation frequency is sufficient to induce tear production when the portion of the member is applied towards a surface of a body portion of the individual; and wherein when the member is oscillated, a part of the portion of the member moves in and out of a housing of the handheld device.
 2. The method of claim 1, wherein the member comprises a cantilevered beam having a free end, the portion being at the free end of the cantilevered beam.
 3. The method of claim 2, wherein the motor is activated to cause the cantilevered beam to undergo bending action in a reciprocating manner.
 4. The method of claim 1, further comprising varying an oscillation speed of the member in response to an amount of force received at the portion of the member.
 5. The method of claim 1, further comprising varying the oscillation frequency of the member in response to an amount of force received at the portion of the member.
 6. The method of claim 1, wherein the portion of the member oscillates with an amplitude that is anywhere between 0.25 mm and 1.5 mm.
 7. The method of claim 1, wherein the oscillation frequency of the member is anywhere from 50 Hz to 300 Hz.
 8. The method of claim 1, further comprising storing information related to a treatment duration, a treatment start time, a treatment end time, an applied force, a treatment frequency, or any combination of the foregoing.
 9. The method of claim 1, wherein the body portion comprises a nose region or an eyelid.
 10. The method of claim 1, wherein the portion of the member is configured for placement over an infraorbital nerve, over an anterior ethmoidal nerve, over an external nasal nerve, or over a meibomian gland.
 11. The method of claim 1, wherein the control comprises a button, wherein the signal is generated in response to a pressing of the button, and wherein the method further comprises de-activating the handheld device when the button is un-pressed.
 12. The method of claim 1, further comprising wirelessly transmitting data to an external device.
 13. The method of claim 12, wherein the data indicates a usage of the handheld device, a force of application by the handheld device, the oscillation frequency, or a combination of the foregoing.
 14. A handheld device for inducing tear production in an individual, comprising: a control at the handheld device; a signal generator configured to generate a signal based on a manipulation of the control at the handheld device; a member having a portion for placement outside the individual; a motor configured to oscillate the member at an oscillation frequency; and a housing; wherein the oscillation frequency is sufficient to induce tear production when the portion of the member is applied towards a surface of a body portion of the individual; and wherein when the member is oscillated, a part of the portion of the member moves in and out of the housing of the handheld device.
 15. The handheld device of claim 14, wherein the member comprises a cantilevered beam having a free end, the portion being at the free end of the cantilevered beam.
 16. The handheld device of claim 15, wherein the motor is configured to cause the cantilevered beam to undergo bending action in a reciprocating manner.
 17. The handheld device of claim 14, wherein an oscillation speed of the member is variable in response to an amount of force received at the portion of the member.
 18. The handheld device of claim 14, wherein the oscillation frequency of the member is variable in response to an amount of force received at the portion of the member.
 19. The handheld device of claim 14, wherein the portion of the member is configured to oscillate with an amplitude that is anywhere between 0.25 mm and 1.5 mm.
 20. The handheld device of claim 14, wherein the oscillation frequency of the member is anywhere from 50 Hz to 300 Hz.
 21. The handheld device of claim 14, further comprising a memory configured to store information related to a treatment duration, a treatment start time, a treatment end time, an applied force, a treatment frequency, or any combination of the foregoing.
 22. The handheld device of claim 14, wherein the portion of the member is configured for placement over an infraorbital nerve, over an anterior ethmoidal nerve, over an external nasal nerve, or over a meibomian gland.
 23. The handheld device of claim 14, wherein the control comprises a button, wherein the signal generator is configured to generate the signal in response to a pressing of the button, and wherein the signal generator is configured to de-activate the handheld device when the button is un-pressed.
 24. The handheld device of claim 14, further comprising an antenna configured to wirelessly transmit data to an external device.
 25. The handheld device of claim 24, wherein the data indicates a usage of the handheld device, a force of application by the handheld device, the oscillation frequency, or a combination of the foregoing. 